Gujarat

Life Cycle management of branded portfolio from IP perspective including competition tracking. IP support for out-licensing projects.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

Strong knowledge of GMP regulations including WHO, EU GMP, PICS, TGA, MHRA, USFDA & other global regulatory guidlines. Expertise in handling CAPA, CCF, deviations, market complaints, product recalls if any.

Preparation & review of New and Existing Products artwork. Responsible to maintained artworks track records in excel.

To perform the role & responsibilities defined as per TMS software. Escalation to Superior for major non- conformities timely.

Assist in the preparation of response packages to Health Canada requests in a timely manner to minimize delays in the submission review process. 

OSD-coating, Compression, Packing, Granulation, Ointment-External Preparation (General & Sterile Manufacturing). Injectable (Aseptic, SIP, CIP, Batch Manufaturing, Bulk Manufacturing, Dry Powder), Oral Liquid

The Selected candidates will work on DST sponsored project at Membrane Science and Separation Technology Division, CSIR-Central Salt and Marine Chemicals Research Institute

Responsible for In-process production related activities in DP manufacturing, filling, and packing sections. Preparation of batch manufacturing records, process validation protocol/report of DP area and its associated records.