Amneal Pharmaceuticals, is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry. Todays healthcare environment requires a new approach and new ideas. While staying true to our reputation for quality, service and value, we are reinventing our processes, our playbook and our creative partnerships. We are focused on delivering outcomes that meet important medical needs, make quality medicines more accessible and more affordable, and provide solutions for tomorrows health challenges. Our leadership and global colleagues are deeply experienced and forward-thinking. We have the capabilities, scale and resources for growth and success. We are nimble and determined. We are Amneal and We make healthy possible.
Opening For Sterile Manufacturing @Amneal (SEZ- Matoda)
We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable unit for our SEZ Matoda Plant.
INJECTABLE REQUIREMENT
1. Sterile Manufacturing (Injectable/Parenteral Unit)
- Designation: Operator/Officer/ Sr. Officer /Executive/ Sr. Executive
- Qualification: ITI/ B.Sc/ Diploma / B. Pharm / M.Sc/ M. Pharm
- Total Experience: 02 to 07 years
- Area: Aseptic & Controlled area operation (Filling, Sealing, filtration, intervention, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization etc.)
- Line: Ophthalmic, PFS, Lyo and Vial
- Machine Exposure: Three piece sterile eye drop machine (Groninger), nenomil, isolator, Trucking, Bosch, fedegree & Optima
- Open Position: 10 Officer & 30 Officer
Desired Profile:
- To observe & follow all rules and regulations of the production department.
- Must be from Parenteral background & exposure to 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 filling machine operation (Groninger), Nanomill Operation, autoclave (Fedegari) Manufacturing and Filtration vessel operation, CIP and SIP processing
- Knowledge of packing area operation and visual inspection
Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP/ GLP and understanding of regulatory requirement will be preferred.
Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization.
You can share CV on neha.modi@amnealindia.com
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