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

- 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)

Valuable analytical, problem-solving, and communication skills

Ability to work independently and in cross-functional teams

Proficiency in MS Office and documentation practices

Required Skills

assurance QA Validation

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Executive/ Sr. Executive- Quality Assurance (Validation) (Chennai)
🏢 Sava Healthcare
📍 Chennai