Executive Quality Control | Bangalore | Syngene International

Job Description

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 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

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 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).

Experience:

• 3-6 years of relevant experience

Educational Qualification: 

• M.Sc. / B. Pharma (Analytical/General Chemistry)/ B. Tech

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 a team and flexible for working in shifts.
• Should be a focused employee.