10 Sep
|
Meyer Organics
|
Thane
10 Sep
Meyer Organics
Thane
The ideal candidate should have robust hands-on experience in IPQA, Vendor Qualification, Process Validation, QMS, audits, investigations, CAPA, and change control within a pharmaceutical manufacturing workplace.
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