Key Responsibilities
- Plan, execute, and document validation activities including:
- Process Validation
- Equipment Qualification (DQ, IQ, OQ, PQ)
- Cleaning Validation
- Utility Validation (HVAC, Water Systems, Compressed Air)
- Computer System Validation (CSV), if applicable
- Prepare, review, and approve validation protocols, reports, and SOPs.
- Ensure validation activities comply with cGMP, WHO, USFDA, EU-GMP guidelines.
- Conduct risk assessments (FMEA, risk-based validation approaches).
- Handle deviations, change controls, and CAPA related to validation.
- Support internal and external audits and regulatory inspections.
- Coordinate with Production, Engineering, QC, and IT teams for validation activities.
- Maintain validation master plan (VMP) and ensure timely execution.
- Ensure data integrity and documentation accuracy as per ALCOA principles.
Required Qualifications
Education:
B.Pharm / M.Pharm / B.Sc / M.Sc / B.E / B.Tech (relevant discipline)
Experience:
2–6 years of experience in QA Validation (pharma/API/manufacturing)
Freshers with strong validation knowledge may be considered for junior roles
Skills & Competencies
Strong knowledge of GMP and validation principles
Hands-on experience with validation documentation
Familiarity with regulatory guidelines (WHO, USFDA, EU-GMP)
Good analytical, problem-solving, and communication skills
Ability to work independently and in cross-functional teams
Proficiency in MS Office and documentation practices
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