Job for M.Pharm, B.Pharm in Sterile Manufacturing, Quality Control at Amneal Pharmaceuticals
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. Today’s 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 tomorrow’s health challenges.
Sterile Manufacturing (Injectable unit /Parenteral Unit)
Designation : Officer/ Sr. Officer/ Operators
Qualification : B.Pharm/ Diploma Engineering / D. Pharm / B.Sc / ITI
Total Experience : 02 to 07 years
Area : Aseptic & Controlled area, Vial, PFS, LYO, Sealing, Filling, capping
Position : 50
Desired Profile :
• To observe & follow all rules and regulations of the production department.
• Must be from Parenteral background
• To be aware and responsible for achieving quality objective and fulfilling the requirements of the quality of the company's service by means of applicable quality procedures.
• Sound technical knowledge of Aseptic area and controlled are related activities.
• Technical exposure and expertise on vial filling, sealing, Autoclave, Lyophilizer, PFS filling, cartridge filling machine.
• Knowledge of Regulatory guidelines and exposure of USFDA audits.
• Knowledge of Eye drop filling machine and related batch mfg. process.
• 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.
Quality Control (QC - OSD) & Quality Control (Technology Transfer)
Designation: Officer/ Sr. Officer/ Executive
Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm
Total experience: 02 to 07 years
Area: Technology Transfer, RM, FP, Stability, LIMS
• Able to perform sampling of raw-materials and packing materials within the specified time frame to support manufacturing activities.
• Should have experience to perform analysis & documentation of Raw-materials, In-process, Finished products, stability & validation samples by using Caliber LIMS software
• Exposure to for management of working/reference standards on Caliber LIMS
• Should have exposure to perform analytical method transfer, method verification and method validation activities as per ICH guideline and as per SOP's
• Exposure to prepare and standardization of volumetric solutions/reagents
• Responsible to perform all activities in laboratory in GLP compliance manner
• Caliber LIMS knowledge is preferable
• Responsible for the analysis & documentation of Raw-materials, In-process and Finished products, stability & validation samples.
• Responsible for the operation & calibration of balances in Sampling room & to maintain its record.
• Responsible for receiving of samples and making entry in the respective sample inward register.
• Responsible for the preparation, handling & management of working/reference standards.
• Responsible for the preparation and standardization of volumetric solutions/reagents and to maintain related documents.
Required Candidate profile
The candidate with good communication and inter personal skills, computer knowledge and exposure to cGMP/ GLP Knowledge and understanding of regulatory requirement is essential.
Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organisation. Who You may walk in for interview with current CV along with CTC proof Appointment letter, Increment letter & last 3 months salary slip & Bank statement, Aadhar & PAN card and 2 passport size photograph.
Those who have already attended interview in last 6 month need not appear again for interview.
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