Executive-Quality Control

Job Description

Designation: Senior Executive Job Location: Bangalore Department: Quality ControlAbout Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Key Responsibilities
• Initiation of QMS elements i.e. Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable.
• Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable .
• Preparation of Specification, Standard Operating Procedure, Instrument Operating Procedures, 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 sheet, calibration data sheets, protocols and reports etc.
• Reviewing LIMS/ELN relevant documentation, SOP s, training presentations, and any other documents related to CSV requirement 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 Softwares 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 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 trainings etc.
• Adherence to Good Laboratory Practice and Good documentation practices.
• Cleaning of workplace and following Good Laboratories Practices while working in QC Laboratory.
• Individuals working in the GMP environment are responsible to document/record the activities contemporaneously and accurately as per Good documentation practices.
• Ensure safety compliance as per Syngene policy and EHSS requirement.
• Responsible for taking any other job allocated by Head QC / Group Leader /Section Head
Educational Qualification:
• 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 Product.
• Familiar with SAP, Chromeleon, EDMS, LMS, TrackWise application software.
• Basic knowledge of MS-Word, Excel, Powerpoint, 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
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.
• 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 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.,

Keyskills :
static datadata sheetscommitment towards work