Quality Assurance Manager

1. Quality System Management:

• Establish, implement, and maintain the

  Quality Management System (QMS)

  as per

  cGMP, WHO, and regulatory norms

  .
• Oversee activities related to

  change control, deviations, CAPA, OOS/OOT investigations, and risk assessments

  .
• Ensure all QA processes align with company policies and current regulatory requirements.
  

2. Documentation & Compliance:

• Review and approve

  SOPs, BMRs, BPRs, validation protocols

  , and analytical reports.
• Ensure all documentation complies with

  Good Documentation Practices (GDP)

  and

  data integrity

  requirements.
• Supervise

  document control

  , issuance, archival, and version management systems.

3. Batch Release & In-Process Quality Assurance:

• Ensure review and release of

  finished product batches

  after verifying compliance with specifications.
• Oversee

  IPQA activities

  in manufacturing and packing areas line clearance, sampling, and process verification.
• Ensure adherence to environmental, hygiene, and cross-contamination control practices.
  

4. Validation & Qualification:

• Plan, execute, and approve

  process validation, cleaning validation, equipment qualification

  , and

  analytical method validation

  activities.
• Review and approve validation master plans and protocols.
  

5. Training & Team Development:

• Lead, mentor, and develop the QA team to maintain high competency levels.
  
• Conduct and monitor

  GMP, GDP, and quality awareness training

  for production, QC, and support staff.

6. Audits & Regulatory Compliance:

• Prepare and ensure readiness for

  regulatory and customer audits

• Conduct

  internal quality audits

  and follow up for timely closure of observations.
• Ensure

  regulatory documentation

  and

  site compliance

  are always maintained.

7. Cross-Functional Coordination:

• Collaborate with

  Production, QC, Engineering, and Stores

  departments for effective quality control and compliance.
• Participate in product and process development reviews to ensure quality considerations are incorporated early.
  

8. Continuous Improvement:

• Drive initiatives for

  process optimization, deviation reduction, and compliance enhancement

  .
• Promote a culture of

  quality ownership

  and

  continuous improvement

  across the organization.

Qualifications & Experience:

• Education:

  M.Pharm / B.Pharm / M.Sc. (Chemistry or related field).

• Experience:

  Minimum

  10–15 years

  in Quality Assurance within a

  pharmaceutical formulation plant

  , with at least

  3–5 years in a Softgel manufacturing setup

  .

• Technical Expertise:

• In-depth knowledge of

  Softgel formulation processes

  ,

  validation

  , and

  cGMP

  .
• Strong understanding of

  QMS, data integrity, and product life cycle management

  .