2-3

Alkem Laboratories Limited established in 1973, is amongst the top five leading Indian Pharmaceutical Companies with global operations

Responsible for release of the product by ensuring review of relevant audit trial of Manufacturing. Strong knowledge of cGMP, ICH guidelines, FDA regulations, and other relevant standards for biologics manufacturing.

Candidate should have experience of granulation, coating, compression, bottle packing, capsulation etc

Candidate having experience in Blister, Cartonator, Container, Topical, Labelling, Bottle, Filling & Counting machine operations + Sterile secondary packing. 

Operate equipment such as Granulation, Compression, Coating, Capsule Filling, Blister Packing, and Bottle Packing.

Process Validation / BPR / BMR/ Equipment Qualification / Audit & Compliance / Engineering & Compliance / Investigation Team

Should have hands on experience in Water samples analysis, In-process Bioburden and BET analysis, MLT analysis of Raw material and packing material, Antibiotic assay by Microbial method.

Having Injectable Experience of Shop floor activities like Filling, Sealing, Stoppering, Garment Washing Machine, Vial Washing, Autoclave, Ophthalmic, Suspensions, filtration, Lyophilizes.

Review of analytical documents with relevant Raw Data, protocols, and Report Etc. Review of tending of the testing of Raw material, Finished Products, Stability samples & Raw materials