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JOB DESCRIPTION
Designation: QMS Investigator
Job Location: Bangalore
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Common Responsibilities:
- Responsible & accountable towards safety & compliance in all the work activities in the own responsibility area(s).
- Monitor & confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment is followed self & direct reports.
- Monitor & confirm that self & direct reports adhere to the highest standards of quality, integrity & compliance for every work activity.
- GMP compliance in all the training activities and meeting training requirements.
- Adherence to Standard Operating Procedures and Operational Control Procedures.
- Support for QMS initiation and on-time closure activities.
Safety and DI Responsibilities:
- Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security.
- Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety.
- Understand all necessary safety protocols and always follow the same to ensure safety for all.
- Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals.
Specific Responsibilities:
- Ensure timely reporting of deviations, appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
- Perform the manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and facilitate proposal & implementation of appropriate CAPA to prevent reoccurrence.
- Participate in the audits and inspections as SME for deviation management and manufacturing investigations.
- Ensure timely proposal and implementation of appropriate CAPA for any audit findings.
- Perform timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting.
- Ensure Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions (CAPA).
- Quality and Compliance Risks
- Operational Risks
- Data Integrity Risks
- Perform and support timely preparation, review and approval of GMP documentations.
- Conduct and/or support training on SOPs, protocols and On-the-Job activities.
- Participate in regular facility walkthroughs, Self-Inspection and Internal Audit for Biologics Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessments.
- Support for implementation of Operational Excellence Initiatives for the Operating Unit (OU).
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.
Pls visit us at https://syngeneintl.com/ to know more about us and what we do.
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