Job Description
Role & Responsibilities - QC- Analytical
Responsible for analysis planning of DS, DP, Stability and protocol-based samples
Responsible for Review of analytical data (Chromatographic and plate based techniques) for routine samples (in process samples, DS, DP release and stability samples) method transfer and method validation.
Responsible for management (qualification and reconciliation) of reference standard in Quality control department
Responsible for Preparation and review of Documents like Specification, STPs, TDS, SOP, CoA. MTP, MVP, MVR, MTR.
Responsible for Coordination with vendor for external calibration and with QC personal for in- house calibration and verification of laboratory instruments and equipmentís.
Responsible for inventory management of QC consumable items (Chemicals, standards, kits & consumables).
Responsible for Analyst qualification & employee training management.
Responsible for initiation and closure of change control and CAPA within its due date.
Responsible for initiation and investigation of incident, deviations, OOS and OOT.
Responsible for URS preparation and IQ, OQ and PQ preparation & execution for equipmentís/instruments.
Should have technical proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR and Capillary Electrophoresis methods.
Should have good comminucation skills, team work and adaptability to work in shifts.
Should have exposure in the GMP environment to adhere the GMP, GLP and GDP practices.
Qualification : M.SC., M. Pharm or Master degree in Biotech or relevant subjects
Experience : 8-10 years of relevant hands on experience in the tasks such CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR and Capillary Electrophoresis analysis (Maurice system), chromatographic and plate based data review and IRS maintenance.
