SYNGENE
Career Opportunities: Senior Executive - Quality Control – API M.Sc. Chemistry / M. Pharma
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Job Description:
Key Responsibilities:
- Good experience in Quality Control with a reputed pharmaceutical company.
- Experience in sampling and chemical analysis of Raw Materials, packaging materials, in process, cleaning samples, Intermediates, Finished Product Samples and validation.
- Perform analysis as per the written procedures and recording the observations contemporaneously in the respective records.
- Knowledge on 21 FR part 11 compliance requirement, ICH and FDA guidelines.
- Awareness about Data Integrity policies/procedures, lab safety and personnel safety
- Experience in the handling of QMS (laboratory incidents, deviations, OOS and OOT).
- Preparing the QC Specifications, protocols and performing the calibration of the QC Instruments.
- Following Good Laboratory Practices while working in QC Laboratory.
- To maintain and clean responsibility allotted for individual instrument.
- Reviewing of Change controls, Validation documents protocols and reports.
- Use of required safety apparels while sampling, analysis and working in the laboratory. Ensure safety compliance as per Company policy and EHSS requirement.
- Responsible to perform the analytical activities as per the approved Specification, MOAs, IOP, GP or protocol wherever applicable and generation of raw data with respect to its correctness, authenticity, completeness and other aspects of data integrity as per Data Integrity policy.
- Laboratory Instrument calibration as per written procedure.
- Trouble shooting of instruments like HPLC, GC, water content of KFT, KFC and Potentiometer.
- Responsible for Training to new joiners and reviewing of training documents and qualification documents.
- Interaction with Production, R&D, QA and other departments for the smooth functioning of the activities.
- Initiation of laboratory incident and deviation.
- Preparation of draft reports and calculation sheets.
- Disposal of sample for analysis after use.
- Taking any other job allocated by HOD or Section Head.
- Analysis of Intermediate, finished product and Working standard qualification as per the specification.
- Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.s
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
- Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.
Educational Qualification: M.Sc. Chemistry / M. Pharma
Technical/functional Skills:
- Familiar with Chromatography and Non-Chromatography analysis of Drug Substances and Drug Product.
- Well experienced in analytical techniques using scientific instruments like HPLC, GC, FTIR, UV, NMR, polarimeter, KF/ Auto titrator, ICP-MS, ICP-OES, coulometry and conventional methods.
- Hands on experience in LIMS (Lab ware), Chrome Leon as an added advantage.
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