The ideal candidate should have strong hands-on experience in IPQA, Vendor Qualification, Process Validation, QMS, audits, investigations, CAPA, and change control within a pharmaceutical manufacturing setting.

Key Responsibilities

- Lead and manage the overall Quality Assurance function across manufacturing operations.

- Oversee In-Process Quality Assurance (IPQA) activities and ensure compliance with approved procedures and GMP requirements.

- Plan, execute and review Process Validation / Process Qualification activities.

- Lead Vendor Qualification and Vendor Evaluation, including approval, assessment, audits and periodic re-evaluation of vendors.

- Establish, implement and maintain effective Quality Management Systems (QMS).

- Review and approve SOPs, specifications, protocols, reports, deviations, CAPA, change controls and other quality documents.

- Ensure effective investigation and closure of deviations, incidents,



OOS/OOT and market complaints.

- Oversee Batch Manufacturing Record (BMR) / Batch Packing Record (BPR) review and release-related activities.

- Ensure timely implementation and closure of CAPA and Change Controls.

- Coordinate and lead internal, customer and regulatory audits/inspections.

- Ensure compliance with applicable GMP and regulatory requirements.

- Monitor quality trends, identify potential risks and implement preventive actions.

- Work closely with Production, QC, R&D;, Engineering, Regulatory Affairs, Supply Chain and other cross-functional teams.

- Drive continuous improvement initiatives related to quality, compliance and manufacturing processes.

- Lead, mentor and develop the QA team to achieve departmental quality objectives.

📌 Head Quality Assurance (Thane)
🏢 Meyer Organics
📍 Thane