Senior Executive - Quality Control - Api Job in Syngene International

JOB DESCRIPTION

Designation: Senior Executive

Job Location: Bangalore

Department: Quality Control - API

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.

Experience: 3 to 6 Years Industrial Experience in reputed Pharmaceutical Quality Control Department

Behavioral Skills:

• Should have good communication skill and should be a good team player.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.