13 Aug
|
Quality HR India
|
Diu
13 Aug
Quality HR India
Diu
Job Description:
Position: AGM/GM - Quality
Location: Daman
Experience: 15 - 25 Years
Industries: Pharma
Responsibilities:
Site Quality Leadership:
To establish and maintain a robust Quality Management System (QMS) aligned with regulatory expectations.
To represent the organization as the Quality Management Representative during internal, external,
and regulatory inspections, ensuring successful outcomes and continuous compliance readiness.
Quality Management System (QMS) Ownership:
To ensure compliance of deviation management, change control, Market Complaint Recall, CAPA systems, OOS, risk assessments, and investigations with regulatory and quality standards.
To ensure for 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 led continuous improvement initiatives to enhance the Quality Management System (QMS)
and drive operational excellence.
Audit Exposure:
EU-GMP, US-FDA, WHO, PIC/s, ANVISA
Batch Release and Product Quality Oversight
To ensure 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.
Training and Development
To establish and led training programs on GMP, GDP, Data Integrity, and regulatory updates for QA and cross functional teams.
To build quality culture across the site through continuous learning initiatives and behaviour-based quality systems.
Cross-functional Collaboration
To collaborate with Engineering, Quality Control (QC), Regulatory Affairs, Supply Chain, and Corporate Quality teams to ensure smooth execution of compliance activities and alignment with regulatory quality standards.
Risk Manageme
📌 Agm/gm Quality Diu
🏢 Quality HR India
📍 Diu