Amneal Pharmaceuticals, Inc 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.
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
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
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
Oral Solid REQUIREMENT
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
Area : Coating (Wruster Coater), Granulation, Compression, Capsulation, Packing and QMS
Machine Exposure : FBE, pam glatt and Blister
Desired Profile :
• Candidates should have hands on experience along with knowledge of 21 CFR compliance in equipment’s like RMG, FBE, Glatt, Co-Mill, V-Blender, Bosch capsule Filling machine, Fette compression machine, Auto coater, CVC Line and Blister packaging line equipment with Track and Trace system.
• Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing/Packaging area of OSD.
• Able to understand & have relevant knowledge of fluid bed equipment
• To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.
• To maintain the areas and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition.
• To impart training of operation and cleaning related SOP to all subordinates and operators
• Co-ordination for IQ / OQ for any new equipment / system
• To perform PQ for any new equipment / system
• To follow all concern departmental SOP’s for day to day operation and cleaning
• To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record
• Able to understand &operate fluid Bed equipment
• To have knowledge of 21 CFR and audit trails etc.
• To perform online documentation with respect to departmental procedures as per good documentation
• Maintaining the change parts for all equipment at manufacturing
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, 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 neha.modi@amnealindia.com & aartig@amnealindia.com
Walk In Interview
Date : 5th March – 6th March, 2022
Time : 9.00 AM – 4.00 PM
Venue :
HOTEL SILVER LEAF, opp. VIA Cricket Ground, Ajit Nagar, Phase 2,
GIDC, Vapi, Gujarat 396191
• 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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