Senior Executive

JOB DESCRIPTION

Designation: Senior Executive

Job Location: Bangalore

Department: Chemical Development – Production

About Syngene

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene's 4500+ scientists offer both skills and the 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 dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Role Purpose:
• Handling of GLR, SSR hydrogenators, ANFD, RCVD
• Handling of strong acids such as H2SO4, HCL, Trifluro acetic anhydride ,etc..
• Pyrophoric chemicals such as sodium borohydride, sodium metal, Boron dimethyl sulfide complex, N-Butyl lithium, etc.
• Online documentation with the GMP and GDP Compliance.
• Handling of solvents and safety compliance with the throughout the operation

Primary Responsibilities:
• Monitoring and control of production operations.
• Coordination for Preparation of the master document required for production like SOP, EOP, ECC, BMR, and PDR.
• Ensure equipment PM & instrument calibration are within the due date by coordinating with EAM team.
• Calibration check of instruments like pH meter and weighing balance in production
• Checking the readiness of equipment to initiate/execute manufacturing activity, ensure the cleanliness of raw material before bringing inside the plant.
• Raw material packing material receipt and check w.r.t BMR/PDR and issue slip with appropriate label.
• Maintain housekeeping of the working area at all times
• Online documentation during batch execution, ensuring documents and annexures are filled and maintained online.
• Ensuring availability of consumables like filter cloth, sample bottles, labels, filter cartridges for shift and next shift.
• Carry out batch charging /filtration / Workup/ Drying activities as per the batch manufacturing record, and product handling and packaging
• Operate the DCS as per the batch manufacturing record, online update of the operations in the batch manufacturing record by referring DCS.
• Update and maintain the equipment logbook/daily checklist
• If any deviation/variation is noted, inform immediately to the supervisor for further proceedings.
• Non-conforming reports and corrective actions-implementation in co-ordination with Senior.
• Cross-checking the mother liquor, aqueous layer spent solvent, spent solid and hand-over for disposal upon concurrence from relevant PRD personnel.
• Sample submission to QC and preparation for next step.
• Taking charge from the previous shift after checking the reaction condition with the batch manufacturing record (BMR) and availability of equipment cleanliness checklist (ECC), raw material and solvent for the next operation.
• Attendance of all training sessions assigned by the training coordinator/calendar
• Ensure Documents and annexures are filled and maintained online.
• Effective performance by coordination with senior management.
• Cooperation with co-workers and focus on good relationships with all cross-functional teams.

Secondary Responsibilities:
• Follow all good health and hygiene practices
• Take care of the shift in-charge operations whenever required.
• Good teamwork by maintaining a healthy environment.
• Focus on a good relationship with all cross-functional teams.

Educational Qualification : MSc / B Tech / M Tech

Experience: 4-8 years

Technical/Functional Skills:
• Monitoring and control of production operations.
• Carrying out manufacturing operations in compliance with current Good Manufacturing Practices, Good Documentation Practices and Data Integrity policy.
• Ensure readiness of the facility at all times.
• Handling and monitoring the shift activities.
• Raw material, packing material receipt and check w.r.t BMR/PDR and issue slip with an appropriate label.

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