Job Description

Acts as first line proxy for Associate. Dir. PQRs Global Quality GBS, India RD Quality Ensures that the APR/PQR for Teva products and review/approval of RD 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 20 professional employees consisting of authors, reviewers, optional approvers and Group Leaders heading different Quality oversights. 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 RD 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 RD 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 RD 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). How you ll spend your day 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 RD Quality Provide oversight for execution of activities within the RD Quality Shared Services unit including but not limited to: Review/Approval of RD 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 RD site SOP s Creation/revision of RD site SOP s Review/Approval of Equipment/Instrument qualification, calibration, and maintenance documents. Review/approval of Computer Systems Validations documents Management and trending of RD Quality kpi s Preparation of presentations for RD 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. JD to be contd.. 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 Your experience and qualifications 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, RD 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, RD 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