Operator-Sterile Manufacturing (Injectable/Parenteral Unit)

Operator-Sterile Manufacturing (Injectable/Parenteral Unit)

work outline icon1 - 6 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Amneal Pharmaceuticals LLC

time outline iconAhmedabad, Gujarat, India

Posted on 16-08-2022

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1 Vacancy

Description

  • To observe & follow all rules and regulations of the production department.
  • Must be from Parenteral background & exposure to Aseptic vial / Bottle filling process is desirable.
  • To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures.
  • Sound technical knowledge of Aseptic area & Controlled area related activities.
  • Technical exposure and expertise on filling & Autoclave machine.
  • Knowledge of Regulatory guidelines and exposure of USFDA audits.
  • Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing area of injectable.
  • Expertise in batch manufacturing and preparation related activities.
  • Knowledge of equipment validation and qualifications in injectable.
  • Preparation & review of BMR-BPR
  • Preferred Exposure for Ophthalmic line: Three piece sterile eye drop bottle filling machine operation (Groninger/Optima), Dynomill Operation, autoclave (Fedegari) Manufacturing and Filtration vessel operation, CIP and SIP processing

Category

Pharmaceuticals

Functional Area

Production / Manufacturing

Preferred Education

ITI (Industrial Training Institute)MSc (Master of Science)DiplomaBSc (Bachelor of Science)BPharm (Bachelor Of Pharmacy)

Key Skills

Good Communication SkillsPharma IndustrySterile Manufacturing (Injectable/Parenteral Unit)Operator

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