Sr. Manager- R&D Quality (PV-QA)

JOB DESCRIPTION (JD)

Role: PV-QA Sr. Manager- R&D Quality

Department: R&D Quality (GPvP QA)

Designation: Senior Manager

Location: Gurgaon

List of Responsibilities / Job Functions:

• Responsible for Implementation of well-defined documented Quality Assurance programme in line
• with applicable regional/global regulatory requirements/obligations, SOPs and SPIL policies & procedures.
• Assist in developing global Pharmacovigilance auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
• Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc. , associated with Sun Pharma Pharmacovigilance operations.
• Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit reports, CAPA reports and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance.
• Facilitate harmonization and consistent implementation of Quality Systems and procedures at sites within the Pharmacovigilance operations, in alignment with Global Quality Policies/Procedures.
• To assure that the CAPAs are adequately addressed and closed.
• Responsible for up-dation of audit master schedule for the GPvP QA audits.
• Responsible to provide inputs for the preparation and submission of monthly report of GPvP QA to the R&D Quality head
• To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA.
• Conduct periodic Quality review board meetings for PV function
• Responsible for review of Pharmacovigilance SOPs for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.
• To prepare and review departmental SOPs
• Responsible for generation, update and maintenance of own personnel records (CV/JD/Training records).
• Conducting Pharmacovigilance procedural trainings within Pharmacovigilance QA group and to operation team on procedures developed by QA.
• To impart induction training to new GPvP QA personnel
• Assure all-time readiness at Sun Pharma PV sites globally for regulatory agency/partner inspections, and implementation of appropriate Corrective and Preventive Actions (CAPA).
• Supervise and participate in Taro cases review.
• Responsible to ensure GxP Computerized Systems at R&D Gurugram (PVG) site are in compliance with the current regulatory standards inline to in house standards.
• Ensure implementation of relevant quality policies, standards and procedures for computerized systems.
• Act as PQL (Process Quality Lead) for Validation of computerized systems at R&D Gurugram (PVG)
• Ensure key documentation of computerized systems at R&D Gurugram (PVG) site consistently meets the required quality standards throughout its lifecycle.
• Author / review the site Computerized System Validation Master Plan (CSVMP) as per the quality procedure.
• Review and approve inventory of computerized systems and infrastructure, at site and ensure its compliance status.
• Review and approve System release and retirement documents as per the quality procedures. Review and approve the periodic activities as per the quality procedures.
• Review and approval of QMS (Deviations, Change Control, CAPA, incidences, investigations etc. ) related to computerized systems.
• Ensure resolution of identified risks/gaps related to computerized systems in a timely manner. Support operations team during corporate audit/ external audits
• Lead to present/discuss and define way forward for fast track remediation of open action items related to computerized systems in site QRB meetings.
• Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives.
• To perform any other responsibilities assigned by the R&D Quality head on as and when required basis

Education and Experience:

• Post Graduate in Pharmacy (M. Pharma)
• Around 15 years of experience

Technical Competencies:

• Auditing skills

Behavioral Competencies / Soft Skills:

• Good spoken and written English
• People Management
• Liaising with different teams