Quality Assurance Manager

1. Quality Compliance & System Management

• Ensure compliance with

  cGMP, WHO-GMP, Schedule M

  , and other applicable regulatory guidelines for injectable products.
• Oversee and manage

  Quality Management Systems (QMS)

  Deviation, Change Control, CAPA, OOS, OOT, and Risk Management.
• Coordinate

  internal audits, vendor audits

  , and support

  regulatory inspections

  (WHO, ISO, USFDA, etc.).
• Review and approve

  Standard Operating Procedures (SOPs), BMRs/BPRs, and validation documents

  .

2. FFS Production Oversight

• Monitor

  sterile manufacturing operations

  in the FFS line including formulation, filtration, filling, and sealing.
• Verify compliance of

  aseptic techniques

  and environmental monitoring in classified areas.
• Review and approve

  line clearance, in-process checks, and batch release documentation

  .
• Ensure effective execution and documentation of

  media fills, process validation, and equipment qualification

  .

3. Documentation & Record Management

• Maintain and control

  document lifecycle management

  in accordance with

  Good Documentation Practices (GDP)

  .
• Review validation master plan, cleaning validation, and stability protocols.
  
• Supervise the archival of controlled documents and batch records.
  

4. Training & Development

• Plan and conduct

  GMP, GDP, and aseptic handling training programs

  for production and QA personnel.
• Develop and mentor QA team to maintain high standards of quality culture.
  

5. Vendor & Material Assurance

• Approve and monitor

  suppliers and contract manufacturers

  through qualification programs.
• Ensure all raw materials, packaging materials, and consumables meet pre-approved specifications.
  

6. Regulatory & Continuous Improvement

• Prepare plant and team for

  regulatory and customer audits

  .
• Manage

  product recall, complaint handling

  , and

  risk evaluation

  .
• Drive

  continuous improvement

  initiatives to enhance product quality and process efficiency.