Title:  Commissioning & qualification and QMS

JOB DESCRIPTION

Designation: Senior Executive

Level: 9- II

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:

• Perform validation of computerized systems for biopharmaceutical manufacturing facilities in the BU and Electronic Records and Electronic Signature (ERES) Validation.
• Perform commissioning & qualification and validation activities for biopharmaceutical manufacturing facilities in the BU.
• Responsible for timely preparation, review and approval of URS, DQ, IQ, OQ and PQ protocols, and reports along with operation staff and QA.
• Responsible for timely preparation, review and approval of other validation documents.
• Coordinate the Calibration Program, Preventive Maintenance Program and Alarm Management for the biopharmaceutical manufacturing facilities.
• Responsible for appropriate planning and timely execution along with review and approval of reports.
• Responsible for robust and optimal practices for maintenance and calibration program to upkeep the facilities.
• Responsible for establishment of appropriate Alarm Management system and implementation.
• Perform investigation for equipment failure to identify root cause and propose and implement appropriate CAPA to prevent reoccurrence.
• Participate in large & small capital projects; finalize conceptual design, basic design and detailed engineering design along with E&M team.
• Perform regular facility walkthroughs and internal audit for Manufacturing Plants and Operations Function to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment.
• Perform Risk Management for Biologics Operations covering following elements and lead proposal and implementation of appropriate risk mitigation actions (CAPA).
• Quality and Compliance Risks Operational Risks o Data Integrity Risks ·
• Perform and support timely preparation, review and approval of Standard Operating Procedures (EOP, IOP and SOP) and review of executed records.
• Perform and support timely proposal and implementation of appropriate CAPA for audit findings, gaps identified in risk assessments and investigations to prevent reoccurrence.
• Perform timely proposal, appropriate impact assessment and implementation of Change Controls
• Conduct and/or support training on SOPs, protocols and On- the-Job activities.
• Participate in implementation of Operational Excellence Initiatives for the BU.
• Participate in timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting.

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.