12 to 15 years Technical and Administrative experience in leading Quality Control activities of Finished Dosage forms in a Regulated environment.
Well versed with cGMP, cGLP requirements of various Regulatory bodies.
Experience of facing audits by National/ International agencies USFDA,WHO, MHRA, ANVISA, PIC/s, Local FDA.
Proven track record of successfully managing a team of (10-15) scientists and Senior executives.
Well versed in operation, maintenance, calibration, trouble shooting of various equipments employed in QC laboratories - HPLCs (automated systems) Spectrophotometers, Autotitrators, GCs,dissolution testers, etc
Experience of Quality documentation systems - dealing with deviations, change controls, OOS, OOT, GDPs,
Experience of documentation systems and procedures as per cGMP norms
Well versed with usage of MS office - Word, Excel and Powerpoint Instrument related softwares
Understanding and experience of working with SAP, LIMS systems
Knowledge, understanding, practical knowledge of concepts of Analytical Method validation, Process validation, cleaning validation, sampling of Raw materials and FDFs, release testing of RMs, bulk/intermediates, FDFs, stability testing, concepts of DI and its execution is a must.
Self drive and initiation will be an added advantage.
Understand and align with Production, QA, RA related requirements
Fact Personnel Pvt. Ltd. shall perspire to continuously research and innovate new methods... of recruitment to facilitate easier and faster recruitment and of quality personnel.
Fact Personnel Pvt. Ltd. shall always perspire to extend its horizon to entire world, and provide world class service to its clients and its candidate as well. It shall perspire to become a knowledge house for its candidate and other people involved so as to contribute to development of every single person. We consider it as our duty as not only to locate the best talent available but also to contribute to the development of individual talents as well in whatever small way we can. Read full description