Role: Head Quality
Location: Bangalore
Dosage Form: OSD

Interested can share their profile on [email protected]

JOB DESCRIPTION:

Lead the overall Quality function covering QA, QC, Microbiology, Analytical Services, Validation, IPQA and QMS for a commercial pharmaceutical manufacturing setting. The role will drive quality strategy, regulatory compliance, scientific excellence, inspection readiness, quality culture and continuous improvement across the site.
Key Responsibilities
1. Quality & QA Leadership
· Lead overall Quality strategy and ensure compliance with cGMP, ICH, pharmacopoeial and global regulatory requirements.
· Provide Quality oversight for manufacturing, technology transfer, NPI, scale-up and product lifecycle activities.
· Drive Quality Risk Management, product quality and continuous improvement across the site.
2. QC, Microbiology & Analytical Services
· Lead Chemical QC, Microbiology and Analytical Services covering RM, PM, IP, FP and stability testing.
· Oversee analytical method validation, verification, transfer, stability,



troubleshooting and lifecycle management.
· Ensure effective management of OOS/OOT, deviations, investigations, CAPA and laboratory compliance.
· Drive laboratory efficiency, data integrity, digitalization and inspection readiness.
3. Validation & IPQA
· Provide leadership for process, cleaning, analytical and equipment/facility validation, including qualification and lifecycle management.
· Oversee IPQA activities across dispensing, granulation, blending, compression, coating, encapsulation and packing.
· Ensure effective control of CPPs, in-process controls, batch quality, deviations and process robustness.
4. QMS & Compliance
· Own and strengthen the site Quality Management System, including Deviations, CAPA, Change Control, OOS/OOT, Complaints, PQR, QRM, SOPs and training.
· Drive root-cause analysis, risk-based CAPA and timely closure of quality actions.
· Ensure strong Data Integrity / ALCOA+ / 21 CFR Part 11 pra

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