Company: Morningside Healthcare Pvt Ltd
Post: Pharmacovigilance- QA Manager
Experience: 10 Years
Qualification: BPharm/ graduation in science
Opening for Pharmacovigilance- QA Manager position
We have an exciting opportunity at Morningside Healthcare for Pharmacovigilance- QA Manager position. This position is based in India with no location constraints (Remote working position)
Person Specification:
Qualification: BPharm/ graduation in science, Auditor accreditation preferred.
Experience: At least 10 years of experience within the quality domain; mainly performing internal and external audits, PV QA role, and PV experience.
Knowledge: GVP Modules, Auditing knowledge
Responsibilities:
- Perform on-site, remote and questionnaire-based audits of all PV partners according to priorities determined by a risk assessment process.
- Management of internal audits for key areas of PV and supporting departments like Artworks, Quality and Regulatory in coordination with other certified quality auditors to review the pharmacovigilance system including its quality system at regular intervals.
- Have a cross-departmental role working closely with Medical, Quality, artwork, Regulatory colleagues supporting their activities to ensure Good Pharmacovigilance Practice {GVP) compliance and inspection readiness.
- Generation and review of Standard Operating Systems and Work Instructions relating to PV audits.
- Having a compliance oversight on all PV processes.
- Management of CAPAs, Deviations and CCs, trend analysis.
If you are interested and have relevant experience, please share your CVs with our HR team at: ssubramaniyan@morningsidehealthcare.com
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