Officer/Sr. Officer-Sterile Manufacturing (Injectable/Parenteral Unit)
1 - 6 Years of Experience
Not disclosed 
Full TimeAmneal Pharmaceuticals LLC
Ahmedabad, Gujarat, India
Posted on 16-08-2022
190 Views
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)Officer/Sr. Officer
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