Job Description
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: FTE/ 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.), Packing area operation and Visual Inspection
Line: Ophthalmic, PFS, LYO, Vial Line, Packing & visual inspection
Positions: (40) Production - Officer/Executive: 10, Operator: 15 and FTE 15
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.
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.