Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business as well as deepening portfolios in institutional injectables, biosimilars and select international markets. Together, we’re rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines.
Job Description
Job Location : SEZ MATODA, Ahmedabad
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 06 years (Pharma experience only)
- Area: Aseptic & Controlled area operation (Filling, Sealing, filtration, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization etc.)
- Line: Ophthalmic, PFS, Cartridges, Lyophilizer and Vial
- Machine Exposure: Three piece sterile eye drop filling machine (Groninger / Optima), Dyno Truking filling and sealing machine, Bosch filling machine, Steam sterilizer (Fedegree)
Desired Profile:
- 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
Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP/ GLP and understanding of regulatory requirement will be preferred.
Note : Candidate should have 01 to 06 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization.
Kindly carry your updated CV along with copies of CTC proof, Appointment letter, Increment letter, last 3 months salary slips, Bank statement, Education certificates & Marksheets, Aadhar & PAN card and passport size photograph, at the interview venue.
If you are unable to attend interview you can share CV on below email id: ajaykumar.pandey@amneal.com
Below points need to be followed:
- The above positions are for experienced candidates only.
Date : 12th February, 2023 (Sunday)
Time : 9:00 am to 2:00 pm
Venue : Amneal Pharmaceuticals Pvt. Ltd.
Plot No 15,16,17 Pharmez, Sarkhej Bavla Highway,
Vil. Matoda, Ahmedabad 382213
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