Vacancy for B.Pharm, MSc in 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.

Manufacturing (Packing / Granulation / Compression / Coating / Capsules / Imprinting)

Officer/ Sr. Officer
Qualification : B. Pharm Only
Total experience :1 to 5 years
Desired Profile :
• 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 perform online documentation with respect to departmental procedures as per good documentation
• 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

Associate/Assistant (Operator)
Qualification : B.Sc./Diploma/ITI
Total experience :1 to 7 years
Desired Profile :
• Operation and cleaning of all manufacturing equipment as per current version of respective SOPs
• Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition
• Maintaining the tooling and change parts for all equipment at manufacturing
• To follow safety rules
• To perform all work related to manufacturing as per instructions of assigned
• To get the required training from supervisors for cGMP and concerned SOP for operation and cleaning

Quality Control (OSD)

Officer/Senior Officer/Executive
Qualification : B.Pharm /MSc. / BSc.
Total experience : 3 to 7 years
Desired Profile :
• To perform analysis Finished Product, In-process and Stability samples as per respective STPs/SOPs/Specifications/protocols & Pharmacopoeial requirement as applicable
• Have an exposure on operation, calibration, Qualification and maintenance of laboratory instrument's / equipment's.
• Have an exposure for the preparation of calibration & Preventive maintenance schedule of laboratory instrument's / equipment's.
• Should have knowledge for the preparation, handling & management of working/reference standards etc. as per requirements.
• Should have knowledge for the SOP's, STP's and GTP's preparation.
• Should have QMS activities knowledge i.e. Change control, Deviations and CAPA's.
• Responsible for the preparation and standardization of volumetric solutions/reagents and to maintain related documents.
• Specific exposure on XRPD, LCMS, GCMS, ICPMS, AAS, Method development, Method Validation
• Knowledge to operate various analytical instruments - UV-VIS spectrometer, KF titration, dissolution test apparatus, Autotitrator, FTIR spectrometer, HPLC
• Knowledge to perform all quality control activities with compliance to cGxP for instrumental, chemical and physical analysis.

The candidate with good communication, inter personal skills, computer knowledge, exposure to cGMP/GLP Knowledge and understanding of regulatory requirements are essential (Preferred 21 CFR compliance)