Executive/Sr Executive/AM-QA Validation For Injectable Formulations

Key Responsibilities:

1. Execution of Plant-Level Validation Activities

• Coordinate and execute

  process validation, cleaning validation, and hold time studies

  on shop floor.
• Monitor and record

  critical process parameters (CPPs)

  during validation batches.
• Ensure adherence to

  batch manufacturing records (BMRs)

  and protocols during execution.

2. Documentation & Review

• Prepare and review process validation

  protocols, reports, and summary documents

  .
• Maintain validation documentation as per SOPs and data integrity requirements.
  
• Compile analytical results and production data for validation reports.
  

3. Compliance & GMP Adherence

• Ensure execution is in compliance with

  SOPs, cGMP, and regulatory guidelines

  (USFDA, EU, WHO).
• Raise, review, and close deviations, change controls, and CAPAs related to validation activities.
  
• Support preparation for regulatory and customer audits, including presentation of validation documents.
  

4. Cross-Functional Coordination

• Work closely with

  Production, QC and Engineering

  teams during validation activities.
• Coordinate sampling, testing, and data collection during process validation batches.
  

5. Training & Continuous Improvement

• Train plant personnel on process validation SOPs and documentation practices.
  
• Support continuous process verification (CPV) and lifecycle management initiatives.
  

Qualifications & Experience:

• Education:

  B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry,).

• Experience:

  26 years in QA Process Validation in

  pharma manufacturing plant

  (OSD/Injectable).
• Hands-on experience in

  protocol execution, data collection, and report preparation

  is must.

Key Competencies:

• Strong understanding of

  GMP, ICH Q8/Q9/Q10 guidelines

  .
• Good knowledge of

  equipment qualification, process validation, cleaning validation

  .
• Strong documentation and communication skills.
  
• Ability to work independently on shop floor with minimal supervision.
  
• Audit readiness mindset and attention to detail.
  

Best in the Industry.

Work location: Jadcherla.

Mention Subject as specific QA-Validations

sanju.r@hetero.com