Instrumentation & QMS Engineer

Designation: Instrumentation & QMS Engineer

Job Location: Bangalore

Department: Engineering and maintenance

About 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.

Job Purpose: To support and maintain the Quality Management System (QMS) in compliance with regulatory requirements, company policies, and industry best practices. The role involves documentation control, audit coordination, CAPA management, and continuous improvement initiatives.

Key Responsibilities:  

• Experience on Project Planning, Project Execution, Budget Management, Vendor and Stakeholder Manager
• Good understanding of Automation, Instrumentation and Quality Management System.
• Good understanding of L2 & L3 Level system i.e. SCADA, DCS, BMS and EMS system.
• Good understanding of Commissioning and Qualification of Equipment’s (Protocol deliverables: URS, QRA, Validation Plan, Design Review, P & ID’s, FAT, SAT, IQ, OQ, PQ’s).
• Experience in leading Quality System Management, Change Control Management, Risk Management and CAPA Implantation

Technical Skills: 

• Good Knowledge of compliances as per regulatory guidelines and standards i.e. 21 CFR Part-11, GAMP-5, ISO-9001, ISA-88 & ISA-95
• Good Software knowledge on Microsoft Office Suits, Trackwise, SAP, EDMS or Validator
• Professional Experience / Qualification:
• Experience in working closely with Pharma and Chemical industries
• Excellent oral/ written communication skills
• Self-starter, with the ability to work and execute independently with minimal oversight.

Educational Qualification:

Bachelor/master’s in engineering, including a minimum of 12-15 years of experience gained in technology implementation/ Product/Project Management in the Pharma space.

Definite experience in Automation, Project Qualification and QMS activities for a minimum of 3-5 years in Pharma Space

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.