Senior Executive - QC analytical

Company: Enzene Biosciences Designation: Senior Executive Office Location: Chakan, Pune Responsibilities: Responsible for analysis of in-porcess, drug substances, drug product, stability and study protocol-based samples. Responsible for instrument calibration and maintenance pertaining to quality control operations like HPLC systems, UFLC systems, maurice systems, plate reader and other simple instruments like pH meter, osmometer and etc.. Responsible for qualification activity and reconciliation of reference standard in Quality control department Responsible for Preparation of Documents like Specification, STPs, TDS, SOP, CoA, MTP, MVP, MVR, MTR. Responsible for Analyst qualification activity and effective training completion as part of routine training management. Responsible for initiation and closure of change control and CAPA within its due date. 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. Responsible for initiation and investigation of incident, deviations, OOS and OOT. Responsible for to follow GMP, GLP, GDP and DI procedure in the quality control department Educational qualifications preferred <M.SC>., M. Pharm or Master degree in Biotech or relevant subjects Required work experience 6-8 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.