Role & Responsibilities - (MVL Analytical)
- To Preform method validation / Verification activity (DS, DP and in-process samples)
- To Preform stability, Qualification of IRS and biosimilarity activity.
- Preparation of documents like Specification, STPs, TDS, SOP, COA, MVP, MVR MTR etc.
- Coordination with vendor for external calibration and with MVL personal for in-house calibration and verification of laboratory instruments and equipment's.
- 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 safety rules at workplace
- Any other task assigned by reporting manager
Experience: 2-5 years of relevant hands-on experience and proficiency in the tasks such CEX-HPLC, SE-HPLC, ELISA, HCDNA by RT-PCR, Maurice, SOLO VPE, HCP, Peptide Mapping, Glycan analysis and Capillary Electrophoresis analysis.
Qualification: M.SC., M. Pharm or Master degree in Biotech or relevant subjects
