Puniska Healthcare (Subsidiary of Amneal Pharmaceuticals) is a new age research-oriented company – focusing on Sterile Injectable products with an objective to sell high quality injectable products in the US, Europe and Other major regulated markets worldwide. For its large scale injectable unit targeting International Regulated Markets, the company invites experienced, result oriented candidates and those who are willing to build their career by demonstrating capabilities & taking independent charge.
We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable unit for our Puniska (Subsidiary of Amneal Pharmaceuticals) 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, Bag printing, filtration, intervention, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization etc.), Packing area operation and Visual Inspection, Lyo Line Operations,
- Line: LYO, Vial Line, Bag line (Isolator)
Positions: (50) Production – Officer/Executive: 20, Operator: 30
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.
Kindly carry your updated CV along with copies of CTC proof, Appointment letter, Increment letter, last 3 months salary slips, 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 amit.sharma@amneal.com
Below points need to be followed:
- All precautions pertaining to Covid 19 pandemic will be strictly followed.
- Please do not attend interview if you are suffering from any health issue (cold, cough, fever or sore throat). We can conduct a telephonic or video meeting with you later.
- Face Mask is mandatory all the time you are in the premises.
- Social distance will be followed strictly.
- Kindly co-operate with security personnel.
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