About this role
- Responsible for Ensuring & monitoring all the GMP & GDP practices/activities (including cleaning & sanitization) related to General, Control & Aseptic area.
- Responsible to generate general purchase indent for departmental general items & prepare shift schedule for manpower as per production plan.
- Responsible for the handling of QMS elements & preparation of production protocols along with review.
- Responsible for preparation, review, revision, control, and implementation of SOPs of sterile manufacturing department.
- Responsible for preparation of production plan vs. actual report on monthly and daily as per the requirement and availability of materials
Skills:
- Filling, stoppering and sealing - Understanding of Operation of glass vial/bottle filling and stoppering machine | Expert Level |
- CIP & SIP - Operating skill for CIP/SIP skids | Expert Level |
- Dispensing - Handling and dispensing procedure for different type of materials | Expert Level |
- Mixing - Understanding of Operation of mixing vessels | Proficient Level |
- Decartoning - Technique for Loading of glass vial / bottle | Proficient Level |
- Washing - understanding of Operation of glass vial/bottle washing machine | Proficient Level |
- GMP Compliance & Documentation - Adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO) | Proficient Level |
- Filtration - Understanding of Operation of filtration vessels | Expert Level |
- Packing - | Basic Level |
- Equipment and Process Validation | Proficient Level
- People Management | Proficient Level |
- Leadership Skill | Expert Level |
- Trouble Shooting/ Problem solving skill | Expert Level |
- Health, Safety & Ergonomics | Proficient Level |
- Audit observation Response writing skill | Expert Level |
Other facts
About Amneal
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- The Deputy General Manager is responsible for ensuring and monitoring all GMP and GDP practices related to manufacturing injectables. This includes generating purchase indents, preparing shift schedules, handling QMS elements, and preparing production reports.
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