Title:  Upstream MSAT

JOB DESCRIPTION

Designation: Associate

Job Location: Bangalore

The Company

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Result Areas

Role-specific:

Functional Responsibilities:

• Responsible & accountable towards safety & compliance in all the work activities in the own responsibility area(s).
• Monitor & confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self & direct reports.
• Monitor & confirm that self & direct reports adhere to the highest standards of quality, integrity & compliance for every work activity.
• Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the direct reports.
• Attend all assigned mandatory trainings related to data integrity, health and safety measures, and monitor & confirm the same for the direct reports.
• Participate in & support the trainings on procedures, protocols and On-the-Job activities.
• Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s).
• Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls.
• Preparation, revision and review of Batch Manufacturing Records (BMR), Packing and Dispatch Record (PDR).
• Issue, Checking and Review of Operations documents.
• Preparation and review of Batch Manufacturing Records, SOPs, PDRs & Protocols.

• Responsible for preparation and review of technical protocols, TTD and BMR

• Participate in planned and unplanned deviation investigation and perform/support related experimentation.
• Understand the facility constraint and perform GAP assessment, Shop floor support for technology transfer and scale up related activities.
• Responsible for documentation of GAP analysis, risk assessment, statistical data analysis and other related technical reports
• Involved in Material risk assessment and prepare base document for preparation of specification.
• Data collection / capturing, monitoring, trending, and analyzing the data from cGMP campaign and authoring of summary reports.
• Trouble shooting of process / product related concerns. Coordination with cross functional team.
• Deliver on other activities assigned by management from time to time.

EDUCATION AND QUALIFICATION:

B. Tech Biotechnology

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.

Pls visit us at https://syngeneintl.com/ to know more about us and what we do.