13 Nov
|
Sava Healthcare
|
Surendranagar
13 Nov
Sava Healthcare
Surendranagar
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 QualificationsEducation: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 solid validation knowledge may be considered for junior rolesSkills & CompetenciesStrong knowledge of GMP and validation principlesHands-on experience with validation documentationFamiliarity with regulatory guidelines (WHO, USFDA, EU-GMP)Good analytical, problem-solving, and communication skillsAbility to work independently and in cross-functional teamsProficiency in MS Office and documentation practices
📌 Executive/ Sr. Executive- Quality Assurance (Validation) (Surendranagar)
🏢 Sava Healthcare
📍 Surendranagar