Production-senior Executive Job in Syngene International

Designation: Production-Senior Executive

Job Location: Bangalore

Department: Chemical Development

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

To execute the production activities in API manufacturing unit. Handle of API equipments like, Reactor, Centrifuge, Vacuum tray drier and Hydrogentaor,

Carry out manufacturing operations in compliance with current Good Manufacturing Practices, Good Documentation Practices, and Data Integrity policy

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

Monitor and control production operations.

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

Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety

Attend training on environment, health, and safety (EHS) measures imparted company

Educational Qualification:

B.Tech in Chemical engineer

Technical/functional Skills:

To execute the production activities in API manufacturing unit.

Exposure of handling hazardous chemicals like NBL, DIBAL-H and corrosive reagents.

Handling of API equipments like, Reactor, Centrifuge, Vacuum tray drier and Hydrogentaor.

Having knowledge about handling of regulatory audits and customer audits.

Carry out manufacturing operations in compliance with current Good Manufacturing Practices, Good Documentation Practices, and Data Integrity policy.

Additional skill sets: Experience on Oligonucleotides or peptides manufacturing will be considered.

Experience:

3-6 years post qualification

Behavioural Skills:

Should have the capability to work in a team and ability to handle demonstrate a good team spirit.

While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills.

Should be proactive while working on allotted responsibility.

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.