Assistant Manager - Research Quality Assurance Job in Syngene International Limited

JOB DESCRIPTION

Designation:Assistant Manager

Job Location: Bangalore

Department: Research 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:

This role involves in tracking the Quality Management System (QMS) elements, ensuring the data integrity principles are followed throughout the data lifecycle, ensuring compliance to system and collaborate with cross functional team on problem solving.

Job Description:

Key Responsibilities:

• The Reasearch Quality Assurance person should review data generated across all experiment phases.
• Data generated in hardcopies as well as in softcopies should be reviewed during routine internal inspections, document reviews and periodic facility rounds.
• ALCOA + principles should be reviewed during document reviews including LNB, eLN reviews.
• Instrument generated raw data and audit trails shall be reviewed on a periodic basis as per pre-defined schedule.
• Instrument/ equipment preventive maintenance and calibration shall be reviewed for adherence to schedule.
• Quality Management Systems (QMS) elements, change control, incidents, CAPA shall be tracked and closed as per requirement.
• Responsible for ensuring logbooks issuance as required for usage in Laboratory. (Logbooks, lab notebooks, annextures, ODS, Calibration sheets, log sheets SOPs etc.).
• Responsible for review and approval of protocols, SOP s, IOP s & Specifications.
• Handling of the QMS documents in Track Wise.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.

Educational Qualification: Post graduate in Science Chemistry / Analytical chemistry

Technical/functional Skills:

• Review and quality governance towards adherence to laid down procedure.
• Ability to implement and maintain compliance enterprise system,21 CFR part 11 compiance
• Collaborate with Cross functional team for successful Client audits.
• Biologics Testing Lab background is desired and will be preferred.

Experience: 9 - 12 years experience in pharmaceutical Quality assurance.

Behavioral Skills:

• Should take problem solving approach to situation.
• High on integrity and ethics at work.
• Team player and collaborate with teams to achieve success.
  

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.