Executive- Taro QA PV oversight
Executive- Taro QA PV oversight
Posted on :
25-02-2025
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1 Vacancy
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Job Description
Job Title: Executive Taro QA PV oversight
Job Location: Gurugram Haryana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: Entry level
Job Description
Position: Executive – R&D Quality GPvPQA Pharmacovigilance as PVQA auditor
Grade: G12A
No of Positions: 2 No.
Job Location: Gurgaon
Job Responsibilities
Desired Candidate Profile
Position: Executive – R&D Quality GPvPQA Pharmacovigilance as PVQA auditor
Grade: G12A
No of Positions: 2 No.
Job Location: Gurgaon
Job Responsibilities
- Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/coauditor for outsourced parties (CROs
- Pharmacovigilance operations. Assist in conducting and reporting audits being a lead auditor/coauditor for Sun Pharma sites associated with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
- Assist in conducting and reporting audits being a lead auditor/coauditor for conducting and reporting audits being a lead auditor/coauditor for outsourced parties (CROs Service Providers Vendors etc.) Affiliates & Partners etc.
- To assist for the preparation and maintenance of CAPA tracker and assure that the CAPAs are adequately addressed and closed.
- Responsible for review of Pharmacovigilance SOPs for completeness clarity and compliance to global/regional policies and applicable regulatory regulations & guidelines.
- Maintenance up to date and in accordance with global expectation a quality system supporting companies supporting PI management
- Review of PSMFs of assigned countries
- Provide support in risk assessment of business partners.
- Participate during qualification of identified vendors for Pharmacovigilance support.
- 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.
- Responsible for updation of audit master schedule for the GPvP QA audits.
- To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA.
- To perform any other responsibilities assigned by the head GPvPQA on as and when required basis
Desired Candidate Profile
- M. Pharm with 23 years of experience in PVQA or Pharmacovigilance operations.
- It is preferred is well aware about GVP modules
- Good oral and written communication skill
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Employment Type
Full Time
Key Skills
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