Executive – Validation Lab Job At Enzene
Enzene is hiring an Executive – Validation Lab in Pune, Maharashtra, for its Validation Lab department. This Executive Job role is ideal for life sciences professionals with hands-on experience in analytical techniques, method validation, and GMP-compliant laboratory operations within a biopharmaceutical environment. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Executive – Validation Lab
- Location: Pune, Maharashtra, India
About the Company
Enzene is a global biopharmaceutical organization specializing in biosimilars and biologics development and manufacturing. The company is committed to scientific excellence, regulatory compliance, and innovation-driven healthcare solutions, offering a collaborative work environment for life sciences professionals.
Educational Requirements
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M. Pharm
Key Responsibilities
- Perform method validation and verification activities for drug substances, drug products, and in-process samples.
- Conduct stability studies, IRS qualification, and bio-similarity-related analytical activities.
- Prepare and review documents, including Specifications, STPs, TDS, SOPs, COAs, MVPs, MVRs, and MTRs.
- Coordinate with vendors for external calibration and collaborate with MVL personnel for internal calibration and verification of instruments.
- Manage MVL labware, chemicals, standards, kits, consumables, inventory control, and stock management.
- Maintain laboratory instruments, equipment, and usage logbooks.
- Conduct analyst qualification activities and provide training to MVL team members.
- Initiate, investigate, and track QMS-related activities.
- Ensure compliance with cGMP and laboratory quality standards.
- Follow workplace safety rules and regulatory requirements strictly.
- Perform additional tasks as assigned by the reporting manager.
Skills Required
- Strong knowledge of analytical method validation and verification.
- Hands-on experience with CEX-HPLC, SE-HPLC, ELISA, and HCDNA by RT-PCR.
- Experience with Maurice, SOLO VPE, HCP, Peptide Mapping, Glycan Analysis.
- Proficiency in Capillary Electrophoresis techniques.
- Understanding of QMS, GMP, and regulatory documentation.
- Strong analytical, documentation, and problem-solving skills.
- Ability to work effectively in a regulated laboratory environment.
- Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
