Title:  QMS-Engineer

Designation: Senior Executive - QMS Engineering

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: Leading quality management system (QMS), ensuring timely closure of KPI : Investigation, change control and corrective and preventive actions (CAPA). Leading Project Documentation of SLIA, URS, CLIA, design qualification and installation qualification and support in execution and compilation.

Key Responsibilities:

• Leading quality management system (QMS), ensuring timely closure of KPI : Investigation, change control and corrective and preventive actions (CAPA).
• Leading Project Documentation of SLIA, URS, CLIA, design qualification and installation qualification and support in execution and compilation.
• Identifying and carrying GAP assessment for central corporate procedure Vs practice and mitigating by taking the Change management process.  Carrying internal audit and finding the observation for procedure Vs practice as part of audit readiness and providing the awareness training.
• Preparation of standard operating procedures, providing SOP trainings.
• SAP-Review and tracking on Calibration, Preventive Maintenance order, Breakdown.
• Conduct periodic self-inspection /internal audits for engineering department.
• Site visit with CFT for vendor audits related to engineering.
• Responsible for  review of preventive maintenance and breakdown summary as per SOP.
• Handling qualification activities of QCM lab.
• Service provider evaluation, Audit & quality agreement.

Educational Qualification: BE/ B. Tech

Technical/functional Skills:

• Preparation of standard operating procedures, providing SOP trainings.
• SAP-Review and tracking on Calibration, Preventive Maintenance order, Breakdown.
• Conduct periodic self-inspection /internal audits for engineering department.

Experience:1-3 years of relevant experience

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