Syngene Quality Control Job – Chemistry & Pharma Candidates Apply
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Job Title: Senior Executive-Quality Control (50741)
Job Location: Bangalore
Department: Quality Control
Elibgility Criteria
M.Sc. / B. Pharma (Analytical/General Chemistry)/ B. Tech
Technical/Functional Skills:
- Analytical experience in GMP Quality Control (APIs & oral solid dosage forms) with a reputed pharmaceutical company/CRO is an added advantage.
- Familiar with Chromatography and Non-Chromatography Analysis of Drug Substances and Drug Products.
- Familiar with SAP, Chromeleon, EDMS, LMS, and TrackWise application software.
- Basic knowledge of MS Word, Excel, Powerpoint, and Teams is mandatory
- Knowledge of 21 FR part 11 compliance requirements, ICH, and FDA guidelines.
- Awareness about Data Integrity policies/procedures, lab safety, and personnel safety
- Experience in handling QMS (laboratory incidents, deviations, OOS, and OOT).
Experience:
3-6 years of relevant experience
Behavioral Skills:
- Strong commitment towards work and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
- Good speaking-listening-writing skills, attention to detail, proactive self-starter.
- 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 be able to work in team and flexible for working in shifts.
Key Responsibilities
- Initiation of QMS elements i.e., Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, and Non-Conformity as applicable.
- Handling of LMS, LIMS, ELN, TrackWise and EDMS software for routine activities as applicable .
- Preparation of Specifications, Standard Operating Procedures, Instrument Operating Procedures, and General procedures. Observation data sheet, calibration data sheets, protocols, and reports, etc.
- Review of Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheets, calibration data sheets, protocols, and reports, etc.
- Reviewing LIMS/ELN relevant documentation, SOP’s, training presentations, and any other documents related to CSV requirements for any enhancements or new implementation/Modules. Collaborating with IT and QA to facilitate validation activities, writing/execution/review of Test Scripts, and effective implementation of LIMS. Ensuring the proper functioning of LIMS application as per the business needs through rigorous testing.
- Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Software as applicable.
- Review of documents and records related to routine operations in quality control. Review of documents in EDMS and TrackWise.
- Involving in Investigation and closure of OOS, OOT, Laboratory incidences, deviation and Non-Conformity as applicable.
- Check consignment documents like COA, MSDS, GRN, TRF, FTRF etc and monitor a sampling of Raw materials, Packing materials, In-process, Validation, Finished products, water sampling, and miscellaneous materials as applicable and certify the accuracy, adequacy, and timeliness of the activity performed by analysts.
- Responsible for imparting training to New joiners, Consultants, Deputation Transfer etc.
- Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.
- Archive and retrieve documents related to the section.
- Act as training coordinator for QC. Assignment of procedural training and recording training in LMS coordinating for internal and External training etc.
- Adherence to Good Laboratory Practice and Good documentation practices.
Cleaning of the workplace and following Good Laboratories Practices while working in QC Laboratory. - Individuals working in the GMP environment are responsible to document/recording the activities contemporaneously and accurately as per Good documentation practices.
- Ensure safety compliance as per Syngene policy and EHSS requirements.
- Responsible for taking any other job allocated by Head QC / Group Leader /Section Head
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