22 Aug
|
Vibcare Pharma
|
Panchkula
22 Aug
Vibcare Pharma
Panchkula
We are hiring a QA Manager to lead Quality Assurance at our manufacturing facility. The role ensures solid GMP compliance, solid documentation, timely batch release, and full audit readiness for regulatory and customer inspections.
- Key Responsibilities
-
- GMP Compliance: Ensure day-to-day compliance with WHO-GMP, Schedule M, and internal quality systems across Production, QC, Warehouse, and Utilities.
- Documentation Control: Review and approve SOPs, BMR/BPR, protocols, formats, and logbooks; maintain strong GDP and data integrity.
- Batch Release: Oversee batch record review and ensure timely product release as per specifications.
- IPQA Oversight: Guide IPQA activities — line clearance, in-process checks, deviations, and documentation discipline.
- Investigations: Lead deviations, OOS/OOT, market complaints, root-cause analysis, and CAPA closure with effectiveness checks.
- Change Control & Risk Management: Handle change controls, impact assessments, and risk-based decisions.
- Validation & Qualification: Coordinate IQ/OQ/PQ, process validation, cleaning validation,
and utilities qualification.
- Audits & Inspections: Face WHO/customer audits, conduct vendor and internal/self-inspection audits, and ensure timely closure of observations.
- Team Management: Train, guide, and develop the QA/IPQA team; run regular GMP trainings.
- Quality Metrics: Track QA KPIs (right-first-time, deviation trend, CAPA ageing, audit scores) and drive improvements.
- Requirements:
Requirements:
- Experience: Minimum 8 years in pharmaceutical QA, with at least 4 years as a QA Manager / lead.
- Education:B.Pharm / M.Pharm (preferred) or M.Sc (relevant field).
- Strong Knowledge: WHO-GMP, Schedule M, GDP, data integrity, CAPA, deviations, change control, and validation.
- Skills: Leadership, audit handling, documentation excellence, problem-solving, and strong cross-functional coordination.
- Tools: MS Office; ERP/LIMS exposure preferred.
- Traits: Detail-oriented, disciplined, account
📌 QA Manager (Panchkula)
🏢 Vibcare Pharma
📍 Panchkula