Assistant Manager / Manager - QA Validation (Injectable)

Role & responsibilities

Validation & Qualification Oversight

• Prepare and maintain

  Validation Master Plans (VMP)

  in alignment with corporate and regulatory guidelines.
• Review and approve qualification documentation including

  URS, DQ, IQ, OQ, PQ, RQ

  , ensuring completeness and compliance.
• Supervise

  execution activities

  and guide the team during validation and qualification stages.
• Oversee and review

  Performance Qualification (PQ)

  ,

  Requalification

  ,

  interim and summary reports

  , and

  addenda

  .

Documentation & SOP Management

• Develop and review

  validation protocols

  , SOPs, and QA documentation related to equipment, facility, and utility qualification.
• Review and ensure compliance of

  SOPs from other departments

  that impact validation and qualification processes.
• Ensure proper documentation control, including version management and approval routing.

Project Management & Execution

• Ensure

  timely completion

  of validation activities in alignment with project milestones and regulatory timelines.

• Review layouts and engineering drawings

  for facilities, utilities, and equipment to ensure compliance and suitability for intended use.
• Maintain and oversee

  revalidation schedules

  in accordance with change control and periodic review programs.

Deviation & Change Control Handling

• Investigate and document

  validation-related deviations

  and

  change controls

  , recommending and implementing appropriate

  corrective and preventive actions (CAPAs)

  .
• Collaborate with cross-functional teams to resolve validation and qualification issues proactively.

Training & Team Development

• Mentor and train QA validation team members on current practices, regulatory expectations, and internal standards.
• Conduct knowledge-sharing sessions to build team capability in

  equipment, facility, and utility validation

  .

Compliance & Continuous Improvement

• Ensure

  cGMP compliance

  in all validation and qualification activities, maintaining a validated state at all times.

Continuously evaluate and improve validation systems, practices, and documentation to meet evolving regulatory requirements.

Preferred candidate profile

• Bachelors or Master’s degree in Pharmacy with

  8–12 years

  of relevant experience in QA Validation within a regulated

  injectable manufacturing facility

  .
• Proven expertise in

  equipment

  /

  facility

  /

  utility qualification

  ,

  process validation

  , and

  cleaning validation

  .
• Strong knowledge of

  regulatory guidelines

  : cGMP, 21 CFR Part 11, EU Annex 1, WHO TRS, ICH Q8-Q10.
• Experience in

  deviation handling

  ,

  change control

  , and

  validation risk assessments

  .
• Ability to read and interpret

  engineering drawings

  , layouts, and P&IDs.
• Hands-on experience with documentation systems and quality management systems (QMS).