QMS

JOB DESCRIPTION

Designation: Deputy Manager

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.

Key Result Areas

Role-specific:

Functional 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.