Job Description

Designation: Executive

Job Location: BMP4

Reporting to: Associate Manager

Job Grade: 9

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.

Responsibilities: \xc2\xb7 Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the reports. \xc2\xb7 Attend all assigned mandatory trainings related to data integrity, health, and safety measures, and monitor & confirm the same for the reports. \xc2\xb7 Participate in & support the trainings on procedures, protocols. and On-the-Job activities. \xc2\xb7 Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s). \xc2\xb7 Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls.

Safety and DI Responsibilities: \xc2\xb7 Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security, and monitor & confirm the same for the reports. \xc2\xb7 Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety and monitor & confirm the same for the reports. \xc2\xb7 Understand all necessary safety protocols and always follow the same to ensure safety for all and monitor & confirm the same for the reports. \xc2\xb7 Proactively identify near-misses & potential incidents and communicate the same to supervisor and/or line manager or through the respective portals and disseminate learnings from those to the team members & any other concerned personnel to prevent recurrence of such events.

Specific Responsibilities: \xc2\xb7 Responsible to co-ordinate C&Q activities through a technical collaboration with various internal and external cross functional teams and SME\'s. \xc2\xb7 Responsible for execution of BMP4 Downstream manufacturing operations by adhering Syngene safety and GMP practices. \xc2\xb7 Preparation and review of qualification documents URS, SLIA, Validation Plan. System Boundary, CLIA. DQ, RA, RTM, IQ, OQ and PQ and applicable deliverables based on qualification procedure. \xc2\xb7 Coordination with cross functional team for qualification document re view and approval. \xc2\xb7 Responsible for execution of installation and operational qualification for BMP4 Downstream equipment\'s. \xc2\xb7 Preparation and re vision of SOPs related to facility and process equipment\'s. \xc2\xb7 Preparation and revision of BMR, checklists and associated written documents in operations. \xc2\xb7 Compliance to current Good manufacturing practices and keep facility ready all the time as per\' regulatory requirements. \xc2\xb7 Maintenance of quality records. \xc2\xb7 Adherence to Standard Operating Procedures and Operational Control Procedures

Verification of operations equipment calibration. \xc2\xb7 Responsible for readiness of prerequisites for the batch activities. \xc2\xb7 Support and technical collaboration with Process development, MSAT and Operational Excellence to handle scale-up and at scale technology transfer aspects.

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.

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Syngene International