Assistant Manager
QA Validation
Job Title:
ASSISTANT MANAGER – QA VALIDATION
Location:
Muppireddipally, Hyderabad.
Experience:
- 9–13 years of experience in QA validation within pharmaceutical/biotech industries.
Role Summary:
Assistant Manager – QA Validation will be responsible for executing, and maintaining validation activities across equipment, processes, utilities, and computerized systems.
Key Responsibilities:
- Prepare, review, and validation protocols, and reports.
- Support/execute qualification/ validation activities for equipment (Cartridge washing machine, Tunnel, Filling machine, Isolator, Automated Visual inspection machine and formulation. vessels-IQ/OQ/PQ) and Utilities qualifications.
- Maintain accurate documentation of validation activities in line with GMP standards.
- Support audits and inspections by providing validation-related documentation and acting as SME.
- Conduct and review risk assessments and support for QMS related to validations.
- Collaborate with cross-functional teams (Manufacturing, Engineering, QC) to ensure smooth execution of validation projects.
Qualifications:
- Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Chemistry, or related field.
- Strong knowledge of GMP, GLP, and international regulatory requirements.
- Hands-on experience in equipment (Filling line equipped with isolator) and utility qualification.
- exposure to regulatory audits (FDA, EMA, WHO, ICH) is essential.