3 - 5 years
4 - 8 Lacs
Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Quality Assurance Pharmacovigilance (PV) Specialist based in Hyderabad.
The ideal candidate brings 3-5 and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments.
Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety.
The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen).
Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO). Provide QA oversight to PV operations including ICSR processing, signal detection, RMP, PSUR/PBRER quality checks, compliance to GVP modules, and CAPA closure after audits.
Additional info: Position Summary: Ensure highest PV standards. Responsibilities: QA oversight across AE reporting, signal detection, risk management; audits per GVP; safety document review; monitor FDA/EMA/ICH/WHO frameworks; lead CAPA; deliver PV QA training; align
Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.
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