Must know process validation cleaning validation verification and hold time studies. Candidate should also have exposure to EU, MHRA, and USFDA regulatory audits.
Candidates having hands-on experience in Analysis of Raw Material, Packaging Material, Finished Goods, Stability, Method Transfer and Laboratory Investigations. Should have sound knowledge of QMS like Deviations, Change Control, Vendor Management etc.
To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members.
Quality Management System oversight and implementation, Validation processes for production systems, In-Process Quality Assurance for General Injectable and Oral Solid Dosage forms.
Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control.
Experienced in handling Primary and secondary packing activities like Blister Packing, Carton packing, Case packing and Serialization. Experienced in Tube filling, Jar filling, Bottle filling etc. in primary packing line machine. Career - Expo at Vizag Packing - OSD & Derma
Expertise in establishing orthogonal approach in understanding the impurities in peptide APIs. Impurity Profiling for Peptides APIs comparing LC and HRMS, High molecular weight impurities and charge based peptide impurities.
Strategic thinking, planning, and execution abilities. Strong and insightful data analytical skills. Proven track record in successful portfolio management, creating strong brands and achieving positive P&L outcomes.