Company Jobs

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

Respond to medical information requests from internal and external customers and ensure the responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs.

Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization.

Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.

B. Pharm, M. Pharm, B.Tech. experience supervising and controlling production areas like Aseptic Filling, Vial Washing, Autoclave and Lyophilizer. Exposure of machine qualification activity will be added advantage.

Trouble Shooting and independently problem-solving ability. Prepare method development and method validation protocols and reports.

Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating. Capsule filling. Expertise in e-BPR and e-log will be added advantage.