Sr Executive

Designation: Senior Executive

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:

Team Member- Handling of QMS, EAM QA, Self-Inspection and Training.

Educational Qualification:  

M.Sc. in Chemistry and B Tech. (Mechanical)

Experience:

Minimum 5 to 8 years of QMS with Pharma experience.

Technical skills:

Preliminary review of Quality notifications such as Change control, Deviation, CAPA, Customer complaints, OOS, OOT for its completeness and correctness in Tack-wise.

Evaluating the effectiveness of implemented CAPA, where applicable.

Review and approval of equipment qualification and engineering related validation documents for its adequacy and accuracy.

Preparation of Quarterly QMS trends.

Reviewing the risk assessments for its adequacy and accuracy.

Responsible for all engineering quality assurance activities and not limited to:

• Review of Calibration planner and schedule.
• Review of PM planners and schedule.
• Review of Engineering and Maintenance documents.
• Review of SOPs of Engineering and Maintenance.
• cGMP monitoring rounds in Engineering and Maintenance.

Participate in investigation & review of investigation reports.

Review of Quality agreements.

Issuance of batch numbers, Batch Manufacturing Records and Packing Dispatch Record.

Preparation and/or review and/or approval of Standard Operating procedures and ensuring the adherence to the guiding SOP.

Preparation/ update training matrix/ training curricula for an employee/ job/ based on the need in consultation with the Department head and reporting manager.

Behavioral 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.

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 accommodation for qualified individuals with disabilities.