Senior Executive

3 weeks ago

pune, India Enzene Biosciences Ltd Full time
JD (Method Validation Lab - Analytical)
To perform method validation/verification activity (DS, DP, and in-process samples) and data review.
To perform stability, qualification of IRS and biosimilarity activity, and data review.
Preparation of documents like Specification, STPs, TDS, SOP, COA, MVP, MVR, MTR, etc.
Preparation and review of documents (Specification, STPs, TDS, SOP, COA, MVP, MVR, MTR, etc.)
Coordination with vendors for external calibration and with MVL personnel for in-house calibration and verification of laboratory instruments and equipment.
MVL labware’s & materials (Chemicals, standards, kits, and consumables) indent and control of stock.
Maintenance and management of laboratory equipment and instruments and usage logbooks.
Analyst qualification and MVL employees training.
Initiation, investigation, and tracking of QMS activities.
Ensure MVL lab compliance in accordance with cGMP.
Strictly adhere to safety rules at the workplace.
Any other tasks assigned by the reporting manager.
Experience
5-8 years of relevant hands-on experience and proficiency in tasks such as CEX-HPLC, SE-HPLC, ELISA, HCD by RT-PCR, HCP, Peptide Mapping, Glycan analysis, and Capillary Electrophoresis analysis.
Qualification
Master's degree in Biotech or relevant subjects.

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