Quality Assurance Manager (OSD Facility)
Immacule Lifesciences
- Location
- Baddi, Himachal Pradesh, India
- Job type
- Full-time
Required skills
- compliance
- cross-functionally
About the role
Immacule Lifesciences
Website:
immacule.in
Job details:
Key Responsibilities
- Lead overall Quality Assurance and Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements.
- Review and approve SOPs, BMR/BPR, specifications, validation/qualification documents, SMF, VMP and other quality documents.
- Manage OOS/OOT, deviations, CAPA, change controls, complaints, recalls and investigations.
- Ensure effective implementation of IPQA, data integrity, quality risk management, self-inspections and audit compliance.
- Approve/review batch release, raw materials, packaging materials, intermediates and finished products.
- Ensure timely execution of process/cleaning/equipment validation, calibration, preventive maintenance and stability studies.
- Lead regulatory, customer and GMP audits, including inspection readiness and timely closure of observations.
- Review and approve Quality/Technical Agreements and monitor contract manufacturers, suppliers and external laboratories.
- Ensure compliance with pharmacopoeial, regulatory and statutory changes and their effective implementation.
- Oversee new product introduction and technology transfer from the Quality perspective.
- Conduct Quality Review Meetings and ensure timely closure of QMS activities.
- Drive continuous improvement and develop a strong quality culture across the organization.
- Lead and develop the QA team through manpower planning, work allocation, KRA setting and performance management.
- Ensure adequate manpower, budget and resources for the QA function.
- Coordinate cross-functionally with Manufacturing, QC, Engineering, Warehouse and other departments to maintain continuous GMP compliance and audit readiness.
Desired Profile
- 12–16 years of relevant experience in Pharmaceutical Quality Assurance, preferably in a regulated/USFDA environment.
- Strong hands-on experience in QMS, audits, investigations, CAPA, deviations, OOS/OOT, validation and regulatory compliance.
- Experience: 12–16 Years
- Qualification: B. Pharma / M. Pharma
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