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 valuable 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.

📌 Senior Executive - QC analytical (Pune)
🏢 Enzene Biosciences
📍 Pune