Title:  Associate Manager

Designation: Associate Manager QA
Job Location: Mangalore
Department:  MSEZ- 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:
Associate Manager – Quality Assurance to manage QMS activities 

Educational Qualification:  M.Sc. (Chemistry), B Pharma/M Pharma or any other equivalent university degree.

Experience:  8 to 12 Years

        Technical Skill: 

• Participation in regulatory inspections and audits and managing responses and corrective actions.

• Ensuring compliance with data integrity policy and identifying the cause of non-compliance.

• Responsible for all engineering quality assurance activities and not limited to: Review and approval of Calibration / PM planners and schedule/ Engineering and Maintenance documents/ SOPs of Engineering and Maintenance.

• Review and approval of Information Technology related documents

• Handling of LMS Training Activities.

• Compilation and Preparation of Quarterly QMS trends

• Preliminary review of Quality notifications (such as Change control, Deviation, CAPA, Customer complaints, OOS, OOT) for its completeness and correctness.

• Preparation and review of Quality Agreement.

• Client communication.

• Vendor Qualification.

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

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

• Reviewing the risk assessments for its adequacy and accuracy.

• Familiar with Trackwise, EDMS, SAP and LMS applications.

Key Responsibilities:

• Establishing and maintaining a robust QMS in accordance with regulatory requirements (e.g., ICH, FDA, EMA).

• Management of Site QMS and trending.

• Management of document archival.

• Site Training coordinator.

Technical/functional Skills:

• Good communication skills and experience in API industry.

Behavioural Skills:
•            Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and      persuasive ability in a team.

•            Good speaking-listening-writing skills, attention to details, proactive self-starter.

•            Ability to work successfully in a dynamic, ambiguous environment.

•            Ability to meet tight deadlines and prioritize workloads.

•            Ability to develop new ideas and creative solutions.

•            Should be able to work in team and flexible for working in shifts.

•            Should be a focused employee.

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.