13 Aug
|
Quality HR India
|
Diu
13 Aug
Quality HR India
Diu
Job Description:
Position: Asst. Manager - QA
Location: Daman
Experience: 8 - 15 Years
Industries: Pharma
Responsibilities:
- To maintain a robust Quality Management System (QMS) aligned with regulatory expectations.
- To handle internal, external, and regulatory inspections, ensuring successful outcomes and continuous compliance readiness.
- To handle compliance of deviation management, change control, Market Complaint Recall, CAPA systems, OOS, risk assessments, and investigations with regulatory and quality standards.
- To manage cGMP/GLP/GDP/GEP followed by all personnel.
- To manage batch release processes, ensuring timely review and disposition in alignment with GMP requirements.
- To manage document control, master batch records, validation protocols, and ensure timely periodic reviews.
- To manage continuous improvement initiatives to enhance the Quality Management System (QMS) and drive operational excellence.
- To manage timely review and approval of Batch Manufacturing Records, Quality Control (QC) reports, and Certificates of Analysis (COA).
- To execute QA release for commercial and validation batches, including product quality review and compliance verification.
- To led training programs on GMP, GDP, Data Integrity, and regulatory updates for QA and cross functional teams.
- To manage quality culture across the site through continuous learning initiatives and behaviour- based quality systems.
- To collaborate with Engineering, Quality Control (QC), Regulatory Affairs, Supply Chain, andCorporate Quality teams to ensure smooth execution of compliance activities and alignment with regulatory quality standards.
- To manage Quality Risk Management (QRM) activities, including risk assessments and mitigation planning to proactively identify and address quality and compliance risks.
- To manage effective coordination with validation teams for timely execution of equipment qualifications, re-qualifications, and periodic reviews of OSD manufacturing equipm
📌 Asst. Manager (Diu)
🏢 Quality HR India
📍 Diu