Senior Executive or Assistant Manager Quality Assurance

Key Responsibilities

Documentation & Compliance

• Review and approval of

  SOPs

  ,

  BMRs

  ,

  BPRs

  ,

  specifications

  , and

  test procedures

  .
• Ensure compliance with

  cGMP

  ,

  ICH

  ,

  WHO

  ,

  USFDA

  ,

  EU

  , and other applicable regulatory guidelines.
• Handling

  change control

  ,

  deviation

  ,

  CAPA

  , and

  out-of-specification (OOS)

  reports.

Internal & External Audits

• Preparation and coordination for

  regulatory inspections

  (USFDA, EDQM, WHO, etc.) and

  customer audits

  .
• Execution of internal audits and follow-up for corrective actions.
  
• Ensure site readiness at all times for surprise inspections.
  

Validation & Qualification

• Review and approval of

  process validation

  ,

  cleaning validation

  , and

  equipment qualification

  protocols and reports.
• Coordination with production and QC for validation activities.
  

Vendor Qualification & Material Review

• Evaluate and qualify vendors as per SOP.
  
• Review and approval of

  COAs

  ,

  RM/PM specifications

  , and

  sampling plans

  .

Batch Release & QA Shop Floor Activities

• Review and release of API batches after ensuring compliance with specifications and documentation.
  
• Perform

  line clearance

  ,

  in-process checks

  , and

  documentation review

  on the shop floor.

Training & Development

• Conduct

  GMP training

  ,

  SOP training

  , and

  quality system awareness sessions

  for cross-functional teams.
• Maintain training records and competency evaluations.
  

Required Skills & Competencies

• Strong knowledge of

  GMP guidelines

  ,

  QMS

  ,

  ICH

  , and international regulatory standards.
• Good understanding of

  analytical techniques

  and

  laboratory compliance

  .
• Sound knowledge of API manufacturing process flow.
  
• Excellent documentation and communication skills.
  
• Proficiency in tools like

  TrackWise

  ,

  LIMS

  , or similar QA systems is an added advantage.

Preferred Industry Experience

• Minimum 6 years of QA experience in

  API manufacturing

  (not formulations).
• Exposure to

  regulatory inspections

  and

  international quality standards

  .