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API Manufacturing Specialist
2 weeks ago
We are seeking a hands-on production expert with deep knowledge of GMP guidelines, ERP proficiency and operational expertise in documentation, safety and equipment handling.
Key Responsibilities:- Carrying out dispensing activities as per applicable procedure
- Carrying out process and sampling activities during the production of Intermediate API's according to approved batch cards
- Knowledge of equipment handling like Reactor, centrifuge, ANFD
- Responsible for recording the observations of reaction parameters on the batch card as per approved procedure
- Filling of all the batch cards, production cleaning, as per approved instructions
- Ensure verification of weigh balances as per applicable procedures
- Maintain work procedure, safety precaution and cGMP
- Ensure housekeeping of plant and cleanliness of the equipment, update the equipment
- Report accidents and irregularities at the work station to the Shift Officer
- Knowledge to perform trouble shooting and root cause analysis
- Develops solutions to complex problems requiring resourcefulness and creativity, innovation and ensures solutions are consistent with organization's objectives
- Work is performed without appreciable direction while exercising considerable latitude in determining objectives and approaches to assignment
- Good understanding of Production procedures
- Good understanding of GMP
- Safety
- Good communication and teamwork skills
- Prior experience in regulated environments, USFDA, WHO-GMP etc
- Exposure to API manufacturing in pharma
- The ideal candidate will have Education: M Sc, Diploma, Chemistry
- Experience: 3 to 5 years of experience in an API industry
We are a community committed to advancing health from the core. We partner with 80 of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we are shaping the future of health worldwide.