5+

Awareness about cGMP & Pharma industry basic knowledge, Basic GMP, safety and computer knowledge. Handling in plant specific area in shift. Good skill to handle API production equipment

Proven experience in investigations, quality systems, or compliance roles. Exceptional command on analytical writing and spoken English.

Operating equipment in Granulation (Tapasya/ACG), Compression (GEA/ Sejong), Coating (Neocota), Roll compaction (Alexander), Capsule Filling (Bosch/MG02), Spray Dryer (Labultima), Track-n-Trace (Optel), Bottle Packing (CVC), Blister Packing (CAM/lMA/ACG), Dry powder filling (Anchor), IPQC, Labelling (CVC/Maharshi), HAPA Printing.

Lead equipment, utility, facility, cleaning, process & media-fill validation. Ensure compliance with regulatory/validation guidelines.

Fresher for Manufacturing and Packing area (OSD/External Prepration)

Experience in QMS activities (Change Controls, Investigations, Incidents, & CAPA preparation) Disinfectant preparation, Media Preparation, MLT, BET & Sterility Method Validations Executions & Documentation

Conduct comprehensive nitrosamine and elemental impurities risk assessments for new products, technology transfers, and commercial products life-cycle changes.

Handling of Reactors, Centrifuges, Driers & Good Documentation, and Good safety Practices.

Experience with regulatory requirements specific to vaccines / biological products. Responding to deficiency letters & authority queries.

Experience in cell based assays and functional testing techniques including ELISA, receptor-based assays, cytotoxicity assays, and bioanalytical methods