Inprocess QA

Designation: Senior Executive 9-II

Job Location: Mangaluru

Department: Quality Assurance

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: Experienced candidate for the Quality assurance department

Educational Qualification:  B.Tech/M.Tech/ M.Sc. in Chemistry

Experience:  Minimum 4 to 8 years Pharma experience in API, QMS, Investigations etc.

Technical skills:

• Responsible for In-process Quality Assurance support for executing GMP manufacturing activities for Mangalore manufacturing facilities.
• Ensure that Site Quality system is always in a state of compliance and ready for Regulatory & Client inspections by following all the necessary quality.
• Provide IPQA Support for product changeover/Dispensing/Manufacturing/Packing &  Plant shut down und maintenance activities.
• Handling of change controls, deviations and CAPAs.
• Ensure assurance of online documentation of activities and integrity of generated data.
• Review of Batch Manufacturing Records, Packing and Dispatch Records, Specifications, Standard Operating procedures, annexures, Validation documents, Qualification documents, audit trails, weighing balance printouts and any other quality documents.
• Perform regular review of logbooks for compliance.
• Evaluation of cross deployment CAPAs,483s and Regulatory surveillance as per procedure.
• Supporting for Vendor management process

Behavioural Skills:

• Adhering to the systems and policies of the company with dedication to work and result oriented approach during the execution of work.
• Self-driven individual with team coordination would be required.

Software Skills:

• Track wise
• EDMS
• SAP

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.