BIOPHARMAX is a leading player in the pharmaceutical and biopharmaceutical industry, committed to delivering high-quality systems and services. We are looking for a skilled and motivated Validation Engineer to join our team. If you have experience in validation within the pharmaceutical industry and are ready to take on challenging projects, we encourage you to apply.
Job Details
Position: Validation Engineer
Experience: 3 to 5 years of relevant experience in Validation in the Pharmaceutical industry
Qualification: BE/B. Tech / M.Sc. / M. Pharm
Key Responsibilities:
- Prepare and draft validation deliverables such as URS, RA, DQ, FAT protocols, IQ, and OQ protocols for Pharmaceutical and Biopharmaceutical systems.
- Facilitate seamless interactions with clients, vendors, and contractors to ensure project alignment and timely deliverables.
- Perform validation activities for computer systems and software, ensuring compliance with regulatory requirements and Good Automated Manufacturing Practice (GAMP) guidelines.
- Execute validation protocols, resolve QA/cGMP queries, and ensure compliance with quality standards, including Good Documentation Practices (GDP) and site safety requirements.
- Strong understanding of national and international GMP guidelines and standards, including regulatory requirements for Computer System Validation (CSV).
- Familiarity with pharmaceutical and biotech equipment, systems, and their validation requirements.
- Knowledge of Computer System Validation (CSV), including experience with GAMP guidelines and 21 CFR Part 11 compliance.
- Willingness to travel extensively within India and internationally, as required.
How to Apply:
Please send your CV to: uma.dubey@biopharmax.com
