Senior Software Quality Assurance Engineer

 United States Pharmacopeia (USP)

Senior Software Quality Assurance Engineer

Hyderabad, India

Description

Summary of the Position

This is a Professional hands-on, non-supervisory IT position in which the incumbent’s main responsibilities are to design, develop, maintain test cases, test scenarios, test data and executes test plans for all software products tested by Software Quality Assurance (SQA) at USP. The incumbent is also responsible to configure and implement automation frameworks, test validation scripts, test data strategies and continuously develop integration scripts to support agile product development methodologies. Installs and updates allowed software on Tester’s machines. Configures and updates settings to ensure Automated Testing Tools functionality is available to all members of the testing team.

Roles and Responsibilities

·         Responsible for creating test plan and perform a test to our R12.2.x implementation of Oracle E-Business Suite consisting of Financials, Supply chain modules, and e-commerce(B2B) platform

·         Responsible to participate in requirements, design, review meetings, and evaluates requirements testability

·         Responsible for maintaining software testing results and process control documentation for audits

·         Works to identify and clarify design and requirements issues. Provides managers with SQA testing estimate on assigned projects

·         Responsible for reports, analyzes, and monitors software defects and performs re-testing

·         Reports present and summarize results of testing

·         Responsible to maintain the master test scenario repository and support UAT testing

·         Responsible for monitors software defects create test results and defect tracking reports

·         Responsible explores and suggests risk-based and business process testing strategies to meet project testing needs

·         Participates in problem solving and collaboration

·         Responsible for training, coordination, and communication with globally located users in testing

·         Responsible to train team members on SQA testing processes, procedures, and test plans

·         Responsible for Installs, maintain, configures Micro Focus Unified Functional Testing (MFUFT) or similar product for all test machines

·         Responsible to uses Micro Focus Application Lifecycle Management (MFALM) for testing and maintaining a central repository of testing artifacts.

Basic Qualifications

·         Bachelor’s degree in computer science or relevant field with a minimum of 8 years or 6 years of professional EBS experience with Master’s degree

·         2+ years proven expertise in Oracle E-Business Suite release 12.2.x or higher with emphasis on modules Financials and Supply Chain

·         Experience with Oracle E-Business Suite Release 12 is a must

·         Oracle Database 11g or higher with strong experience in SQL and PL/SQL

·         Minimum 2 years’ experience in developing Cucumber, Selenium Webdriver, Performance testing,

Manager - Data Strategy & Analytics

 United States Pharmacopeia (USP)

Manager - Data Strategy & Analytics

Hyderabad, India

Description

Summary of the Position

The Data Strategy and Analytics Manager is a supervisory position with the Pricing, Strategy, and Analytics department. The Data Strategy and Analytics team performs a centralized business analytics function for USP – supporting all levels of the organization including the Executive Team. The Data Strategy and Analytics Manager perform an integral role in relation to data collection, modeling, and analysis. The Data Strategy and Analytics Manager perform and coordinate various analyses surrounding business problems and partners with the manager to make recommendations accordingly. She or he communicates analytical results to non-technical audiences – translating analyses into concise and clear business recommendations.

Roles and Responsibilities

·         Lead analytics for the India Site including developing and managing self-serving dashboards and providing insights and recommendations.

·         Collaborate with Sales and Marketing teams in India and global sites and conducts in-depth analysis to support strategic planning.

·         Build and manage the Analytics team at the India site as well as act as an individual contributor when needed.

·         Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities.

·         Empower employees to take responsibility for their jobs and goals. Delegate responsibility and expect accountability and regular feedback.

·         Provides clear, thorough, accurate, and consistent analyses from a variety of disparate data sources including, but not limited to, sales transactions, operations, and web traffic data.

·         Creates highly sophisticated analytic frameworks and functional models to provide recommendations for solving key business problems.

·         Uses internal and external data sources to develop analytical models to answer business questions.

·         Acts as a thought partner with colleagues across USP on how to resolve unique business problems using analytics. Partners include program unit heads, site heads, and strategy leaders.

·         Takes complex data and distills it into relevant information, documents, and/or presentations for multiple-levels of leadership audiences.

·         Partake in data quality improvement and integration project as part of USP long-term data strategy.

·         Sets and manages internal partner expectations related to specific deliverables.

·         Project examples include forecasting, sales and revenue analysis, customer segmentation, business development, and growth strategy.

·         Develops ad hoc reports and analyses as needed.

·         Other duties as assigned.

Basic Qualifications

·         MBA or other relevant master’s degree preferred such as Data Science, Analytics, Statistics, Information Systems, Computer or Health Science related fields.

·         Undergraduate degree required. Preferred majors in pharmacy, chemistry, biology, or other science

Scientist III Analytical Research and Development

 United States Pharmacopeia (USP)

Scientist III Analytical Research and Development (NMR)

Hyderabad, India

Description

Summary of the Position :

This is a non-supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the Scientist - III responsible for providing analytical support for characterization or identification samples received from various laboratories of USP India such as ARD, Synthetic chemistry, RSL, Verification, CDL and Biologics. The Scientist III performs a variety of non-routine and routine analytical tests, including evaluation of reference standards, development or validation (as per requirement) of official methods, evaluation of packaging materials and stability studies, and general research in analytical chemistry.

Roles and Responsibilities

 Responsible for operating, and maintenance of 500 MHz NMR instrument, recording and interpretation of NMR spectra for samples submitted by the Synthetic Organic Chemistry Lab, Reference Standards Lab, Biologics & Biotechnology Lab, and other sources as per ISO 17025.

 Develop appropriate NMR methods for identified of certain projects from time to time

 Work in open access instruments to support a team of ARD scientist and deliver result in a timely manner

 Responsible for small and large molecules structure elucidation using NMR spectroscopy

 Support to synthetic R&D projects from start to completion as per ISO 9001

 Performs other related duties as required Assist and maintain the safety aspects in the laboratory

 Prepare for ISO‐9001 & ISO‐17025 audits and related activities

 Help develop Standard Operating Procedures and policies in ARD Lab

 Coordinate with Quality Assurance staff to ensure the implementation of corrective actions

 Ensure that the calibrations of the equipment are performed as per the schedule.

 Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.

 Ensure the lab requirements like glassware, chemicals and columns for NMR lab.

 Ensure to follow USP Policies and Procedures.

 To involve in project execution, method development and validation of USP/NF/DSC/FCC/OTC projects as and when required.

Basic Qualifications

 M.Sc. in Analytical Chemistry / Organic Chemistry, from a well‐recognized University in India or abroad and required not less than 6 ‐8 years’ experience in handlinØg the NMR spectrometer.

 Extensive NMR knowledge both in running the equipment and interpretation of results and characterization of the compound by spectral techniques (NMR, MASS and IR). Must possess a strong work ethic and a solid record of problem solving and technical results.Ø

 Good technical writing and verbal communication skills are required. Good interpersonal skills and proven ability to function in a team‐oriented environment are necessary. Understanding of GMP / ISO‐IEC 17025 Guidelines is a requirementØ

Preferred Qualifications

 Proficient in small molecule structure elucidation using NMR.

 Experience on biological molecules such as peptides, proteins and vaccines would be an added advantage.

 Knowledge of qNMR, solid state NMR and multinuclear NMR operations is an advantage.

 Must be familiar with electronic notebook documentation of experimental procedures.

 Proven track record of consistently delivering projects on time and with high quality.

 Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.

 Takes personal responsibility for delivery of projects to customers.

 Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal.

 Expertise with Bruker NMR software‐ automation software & hardware including cryo‐probes.

 Comprehensive understanding of the science involved in the development of synthetic organic

Senior Director, Regional Program Operations

 United States Pharmacopeia (USP)

Senior Director, Regional Program Operations (Regional General Manager) South Asia

Hyderabad, India

Description

Summary of the Position

This is a supervisory leadership position that will lead the development and execution of strategies to advance public health through USP quality standards and allied products and services with the objective to enhance the quality of medicines, dietary supplements, and foods. This role is directly responsible for leading externally facing functions for USP in the South Asia region including customer engagement, customer service, external affairs including public policy and regulatory affairs, government & stakeholder relations, scientific affairs as well as education programs, verification programs, monograph donations, market research and insights, data analytics and other relevant activities.

The incumbent will establish strong and collaborative relationships with senior industry leaders and leading public officials and stakeholders in South Asia and represent the organization at high-level events. The incumbent will be responsible for market situation and analysis, new products/service introduction & launches, for the successful implementation of USP programs and new business development and will lead USP’s growth effort in the region by applying an in-depth understanding of the market, public health priorities, and strategic acumen.

Roles and Responsibilities

·         General Management:

·         Lead and manage USP South Asia’s Marketing, External Affairs, Scientific Affairs as well as Strategy & Insights units, aligned with USP corporate culture, mission, and public health programs in the region.

·         Matrix Management: Ensure that regionally based department staff collaborates closely with counterparts from across the USP global organization.

·         Talent and Leadership Development: Ensure talent recruitment, development, and retention as well the establishment of a leadership pipeline in the department

·         Strategy and Marketing :

·         Lead the development and execution of regional strategy, plans and programs, both short- and long-range to support business goals and the objectives of the organization by working closely with the USP global organization.

·         Identify and execute local growth plans in priority countries within the region, in partnership with the USP Global Organization.

·         Develop and hold a sophisticated understanding of the region to establish strategies for the priority countries.

·         Oversee the Strategy and Insights team (Includes Market Research and Data Analytics teams) who support global projects from India.

·         Customer Engagement (CE):

·         Drive visibility and engagement by representing USP in various industry forums and outreach, including CEO/CXO level executives in the industry, and continue to strengthen USP’s brand awareness

·         Lead locally based Customer Engagement (CE) staff by supporting and reviewing the implementation of regional CE goals. Develop capability among second-level leadership. Oversee the channel partners/distributors strategy and their performance in the region for ensuring new business development and sustaining existing business

·         Develop a keen understanding of customer needs, identify opportunities for USP to address those needs, and further the USP Mission. Work closely with the USP global organization to convert customer need and USP opportunities to programs where feasible

·         Promote all USP products, services, and programs at trade events, conference using the appropriate media, collateral, and promotional tools

·         Oversee, guide, and develop the capabilities of Customer Service Staff and ensure they are able to provide superior levels of support to all stakeholders.

USP Education:

·         Lead the USP Education initiatives in South Asia including the development of a long-term strategy and execution for scaling up capacity-building support to the manufacturers to enable them to achieve excellence in quality.

·         Lead the staffing business development efforts for the success of education initiatives. Work closely with the USP India Site leadership team to develop faculty and programs suited for industry

·         Develop self-sustaining business models for the delivery of USP training programs to meet the capability needs of the industry. Seek and implement collaborations where suitable to deliver outcomes

Monograph Donation

·         Lead the team to coordinate monograph acquisition activities from customers, starting with identifying potential sponsor organizations, approach established contacts, obtaining a donation, and maintaining communication and relationship on an ongoing basis with donor organizations.

International Government and Regulatory Affairs/Stakeholder Engagement (IGRA/SE):

·         Develop and maintain strategic collaborative relationships with stakeholders in the public sector and industry to advance public health objectives that align with USP’s capabilities and strategic plan in the region

·         Lead locally based IGRA/SE staff and be accountable to build and execute public policy, stakeholder relations, and advocacy plan to advance USP's mission and strategic goals in South Asia.

·         Develop and implement a communications strategy for the region in close collaboration with the global organization

·         Manage and advance the execution of MOUs with stakeholders. Develop and maintain long-lasting

Scientist II, RSL

 United States Pharmacopeia (USP)

Scientist II, RSL

Hyderabad, India

Description

Roles and Responsibilities

·         Executing the analytical tests allotted by Project or Group Leader.

·         Verification of test protocol and giving test kit approvals, if required.

·         Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.

·         Responsible for preparation of project evaluation reports.

·         Responsible for sample tracking and chemical inventory tracking in the laboratory.

·         Coordination with group leader to ensure completion of the projects allotted to the team.

·         Initial review of the project reports and documents and assisting the group leader when required.

·         Completing the project as per the timelines and trouble shoot the scientific aspects of the projects on need basis.

·         Responsible for preparation and review of SOP’s, protocols, reports etc.

·         Responsible for performing the calibration of the equipments as per the schedule.

·         Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.

·         Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.

·         Taking up any additional responsibilities assigned by group leader from time to time.

·         Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.

Basic Qualifications

·         Ph.D. in Chemistry with 1-2 years or Master degree in Chemistry with 4-6 years of relevant laboratory experience.

Preferred Qualifications

·         Proven track record of consistently delivering projects on time and with high quality. Proficient with pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP, FCC, NF, etc.). Expert in Chromatographic analysis, especially in HPLC and troubleshooting, proficient in other related analytical instrumentation (Titrations, IR, KF, UV, Thermal, Elemental analysis etc.), Takes personal responsibility for delivery of projects to customers. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal. Having knowledge of Empower software, ELN, ERP, QR coding system are added advantages. Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.

USP offers an impressive benefits package, including:

· Comprehensive individual and family health insurance plans

· Annual Master Health check-up plans

· Generous paid holidays, vacation leave

· Transportation services for office commute.

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the

Scientist III, Analytical Research and Development

 United States Pharmacopeia (USP)

Scientist III, Analytical Research and Development (Complete Analysis)

Hyderabad, India

Description

·         Roles and Responsibilities

·         Prepare for & execute the Synthetic R & D and collaborative testing projects as per ISO/IEC 17025.

·         Ensure the projects requirements by Coordinating with the supervisor

·         Ensure the availability of chemicals, standards and test licenses.

·         Involve in project acceptance & approvals.

·         Execute projects per the approved test protocols if assigned.

·         Responsible for preparation of SOPs, protocols, reports, etc.

·         Ensure the projects requirements by coordinating with the Purchasing department.

·         Complete ARD‐ (USP‐NF & CDL) and collaborative testing projects within timelines by coordinating with Manager.

·         Responsible for preparation of the records and documents.

·         Ensure that the calibrations of the equipment’s are performed as per the schedule.

·         Prepare, execute and complete IQ/OQ/PQ of new instruments.

·         Indent the required glass ware, chemicals and columns for the ARD projects.

·         Maintain GLP & implement safety procedures while working in Lab.

·         Perform other Projects whenever free from ARD activities.

·         Perform other duties as assigned

 Preparation and planning for ISO‐9001 & ISO‐ 17025 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.

 Participates in USP cross‐functional teams as appropriate

Required Skills:

·         Proficient with pharmaceutical testing requirements involving compendial methods for reference materials.

·          Expert in HPLC and GC analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, and thermal analysis techniques etc.).

·          Knowledge of handling LCMS and GCMS will be added advantage.

·          Working knowledge of computer applications, such as MS Word and MS Excel are required.

·          Good interpersonal skills and proven ability to function in a team‐oriented environment are necessary.

·          Proven track record of consistently delivering projects on time and with high quality.

·          Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.

·          Takes personal responsibility for delivery of projects to customers.

·          General chapter information, Empower and NuGenesis will be preferred.

Required Experience:

M.Sc. in Analytical Chemistry / Organic Chemistry, from a well‐recognized University in India or abroad and required not less than 6‐8 years’ experience in Analytical lab.

 Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, FTIR, UV‐Visible, wet chemistry, etc. Must have experience with electronic notebook documentation of experimental procedures (LMS) and QMS system.Ø

 Good technical writing and verbal communication skills are required. Good interpersonal skills and proven ability to function in a team‐oriented environment are necessary. Understanding of GMP / ISO‐IEC 17025 Guidelines is a requirementØ

USP offers an impressive benefits package, including:

· Comprehensive individual and family health insurance plans

· Annual Master Health check-up plans

· Generous paid holidays, vacation leave

· Transportation services for office commute.

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for