Teva Sr Mgr Quality Assurance 

India, Karnataka, Bengaluru 

495079805

This incumbent

• Acts as first line proxy for Associate. Dir. PQRs Global Quality GBS, India & R&D Quality
• Ensures that the APR/PQR for Teva products and review/approval of R&D Documents are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Defines team operating standards and ensures essential CORP & local procedures are followed based on knowledge of own discipline.
• Manages and supervises a team of<
• Is accountable for the performance and results of the team under his/her responsibility within the function Global Quality GBS.
• Creates and adapts departmental plans and priorities to address resource and operational challenges for PQR compilation, review, approval and for review, release of R&D documents.
• Ensures that decisions are guided by CORP policies, procedures and Global Quality´s business plan.
• Receives guidance from Associate Director Global Quality- GBS India and R&D Quality, Sen. Dir. Quality Strategy and Shared Services and Global Head RD Quality, other Managers in Global Quality GBS and GBS, Global IT, EMSO Quality affiliates, Commercial Quality EU & IM, TGO and R&D Quality
• Provides technical guidance and training to employees, colleagues/related managers and/or TEVA internal customers.
• acts as escalation point within the interaction between the Team and external suppliers or internal stakeholders.
• Participates in Quality councils and delivers input for the performance of the team/teams under his/her responsibility.
• Is responsible for employee performance objectives in the team, conducts performance reviews and recommends pay actions.
• Supports modernization by use of relevant IT Tools.
• Ensures continuous improvement of efficiency and compliance by establishing and monitoring relevant KPIs (OPEX).

Job responsibilities

A) Approval of PQR’s

The owner of the function

• Approve Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) which do not require approval step by any other TEVA /non-TEVA stakeholder like QPs, RPs or FvPs.
• Recommend actions and communicate to internal and external stakeholders for identified actions as part of the Approval process to improve quality of products (CAPA)
• Support and guide in escalation of PQR issues and initiate and conduct meetings / telecons if required on priority.
• Escalate the issues of the team to higher management for non-responsive CMO’s and TEVA’s internal stake holders

B) Supervisor R&D Quality

Provide oversight for execution of activities within the R&D Quality Shared Services unit including but not limited to:

• Review/Approval of R&D documents including analytical methods, validation protocols and reports, study protocols and reports, specifications, and executed batch records.
• Release of Materials
• Provision of Inspection Readiness support
• Provision of support for generation and maintenance of QTA’s
• Performance of Corporate Gap Assessments against R&D site SOP’s
• Creation/revision of R&D site SOP’s
• Review/Approval of Equipment/Instrument qualification, calibration, and maintenance documents.
• Review/approval of Computer Systems Validations documents
• Management and trending of R&D Quality kpi’s
• Preparation of presentations for R&D site’s Quality Council meetings
• Data reviews

C) Quality Management Systems

• The owner of the function
• Ensures that the local quality management system is maintained in the team under his/her responsibility
• Ensures that the local Quality Management System is compliant with respective regulatory guidelines and TEVA´s CORP QMS (Gap Assessments)
• Approves process of change controls and deviations
• Writes or approves local SOP’s and its related templates.
• Monitors self-inspections and related CAPA of the team under his/her responsibility as per timelines and verification of compliance report.

D) Performance Management

• Monitors and compiles the KPI scores of the team under his/her responsibility and supports the team to improve their efficiency.
• Participates in the customers council meetings and supports the effectiveness of the councils
• Participates in the Monthly Quality Council of the PQR-Center and enhances the effectiveness and efficiency of it by suitable reports/metrics and continuous improvement.
• Writes or evaluates the monthly reports as needed by various stakeholders.
• Proactively initiates and leads continuous process improvement projects to improve efficiency groups across the team.

E) Training

The incumbent

• Performs GMP training and on the job training.
• Imparts training on procedures as needed.
• Reviews the training status of the team and regularly verifies that training was performed in time and successfully.

F) Miscellaneous Support

The owner of the function is responsible for

• Maintaining Employee Central and other relevant Master Data
• Responsible for approval of PO’s related to purchase of PQR’s
• Review the invoicing cost involved with respect to the status.
• Approval of POs in SAP- for hiring and other requests like purchase orders for costs involved in updation of software
• Write or Review monthly report to be presented to higher management
• Approve various access levels for all reportees for various software on an annual basis
• Monitor HC justification for every approval
• Maintain CAPA reports and Risk Assessments on the performance of the department in cases those are requested by health authorities
• Support the maintenance of the IC QTA –with current updates
• Ensures the robust handover procedure in case of exits

• Bachelor’s degree in pharmacy or Natural Sciences, master’s degree in pharmacy or Natural Sciences
• More than 12 years of experience in QA / QC, R&D function in the pharmaceutical industry.
• More than 5 years of experience in a managerial role.
• Well-founded knowledge on worldwide cGxP regulations.
• Excellent English language skills, other language skills could be helpful incl. local Indian Languages
• Very Good communication skills and ability to work in a matrix structure.
• Very good knowledge of Computerised Systems in TEVA´s IT landscape (Trac-Wise, SAP, LIMS, Global Insights, Hot Dog Glorya, Veeva etc.)
• Good understanding of manufacturing, QC, R&D and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Ability to guide a team and influence other stakeholders
• Ability to work as manager in a matrix organization (GBS) and act properly on conflicting interests
• Mobility required