M.Pharm

Exposure to OSD manufacturing operations like granulation, compression, coating, pellet coating capsule filling and packing.

Planning and execution of batch packing activities such as Dispensing & Line clearance. Expertise in handling Blister, Bottle and Sachet packing machineries like BQS, CAM, Maspack, Auto Cartonator etc.

Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia

A Scientific Professional with Bachelor, Masters degree in Pharmacy, Life Sciences, Chemistry, Biological Sciences with a business management degree, MBA is preferred. A minimum of 9 years experience with at least 5 years in a technical field analytical background and at least 4 year of experience in a customer facing role.

Co-ordination with product development team to keep track of various projects. Sample seeding from suppliers for project initiation. Co-ordination with supplier, principle for arranging quality documents.

Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure as applicable

Exposure in investigation of UPD , OOS, OOT, EM and Change control & CAPA Management. Preferable for exposure in Regulator}’ and FDA Audits, Knowledge and exposure for aseptic operations and principal of its relevant equipment.

2-7 years of experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic and control area operation, documentation, both SVP and LVP manufacturing etc.

Investigation Tools, 5Y, Fish Bond, 6M, QMS Activities, Change Control, Deviations, CAPA, Monthly MIS Data. IPQA - OSD and lnjectable, AQA, QA Stability, APQR, Documentation, Validation, QMS, CQA, Artwork