Senior Executive_Method Validation Specialist
2 days ago
Job Title: Senior Executive Method Validation Specialist
About Us: Enzene Biosciences Ltd is a leading biotechnology company that specializes in the development and manufacturing of high-quality pharmaceuticals.
Role Description:
We are currently seeking an experienced Senior Executive Method Validation Specialist to join our team. The successful candidate will be responsible for performing method validation, stability sample analysis, and reviewing analytical data.
The ideal candidate will have hands-on experience in tasks such as CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis analysis. They will also be responsible for coordinating with vendors for external calibration and working with QC personnel for in-house calibration and verification of laboratory instruments and equipment.
In addition to these responsibilities, the Senior Executive Method Validation Specialist will be required to maintain and manage laboratory equipment and instruments, qualify analysts, and provide training to QC employees.
They will also be responsible for initiating, investigating, and tracking QMS activities, ensuring compliance with cGMP regulations. A Master's degree in Biotech or a relevant field is required, along with 5-8 years of relevant experience.
Key Responsibilities:
- Perform method validation, stability sample analysis, and review analytical data.
- Coordinate with vendors for external calibration and work with QC personnel for in-house calibration and verification of laboratory instruments and equipment.
- Maintain and manage laboratory equipment and instruments.
- Qualify analysts and provide training to QC employees.
- Initiate, investigate, and track QMS activities, ensuring compliance with cGMP regulations.
Requirements:
- Master's degree in Biotech or a relevant field.
- 5-8 years of relevant experience in tasks such as CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis analysis.
- Hands-on experience in laboratory equipment and instruments management.
- Excellent communication and teamwork skills.
Salary: ₹1,200,000 - ₹1,800,000 per annum (dependent on experience).
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