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 Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols, reports, etc.
Review of Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols, reports, etc.
Reviewing LIMS/ELN relevant documentation, SOPs, 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
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 Product.
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 the handling of QMS (laboratory incidents, deviations, OOS, and OOT).
3-6 years of relevant experience
M.Sc. / B. Pharma (Analytical/General Chemistry)/ B. Tech
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 a team and flexible for working in shifts.