Company Jobs

As Regulatory Professional II, the candidate will be responsible for making the timely submissions to the Health Authorities worldwide.

Perform all the labelling update activities and tracking in systems for record maintenance with respect to New Product Development NPD label creation and Product Life Cycle Management PLCM update for products in USA and Canada market

Should have detailed knowledge as well as experience of working for an injectable manufacturing process. Should have compendia and regulatory knowledge of aseptic processing and controls and Contamination control strategy program.

Having good experience of method development on HPLC and GC instruments and other analytical instruments. Having knowledge of wet analysis

OSD, Oncology and Cosmeceutical (Sunscreen, Anti Acne, Moisturizer, De-pigmentation, Baby products and soaps). Exposure of Regulated, Semi Regulated & India Markets.

Environmental monitoring of manufacturing clean room area. Non-viable particle monitoring of manufacturing clean room area. Personnel monitoring. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g. plates, swabs, etc.

Candidates with experience in handling of sophisticated instruments e.g. HPLC, GC, UV, IR, Dissolution apparatuses and other laboratory equipment are preferred.

Exposure of QMS activities Exposure of Ampho, Bupivacaine Autoclave Operation and Supervision Lyo Operation and Supervision Regulatory Audit exposure Online documentation of BMR and log books during execution of batches

In-Process, FG and Stability, Analytical Instrumentation - HPLC, UV and Dissolution