Preparation of Clinical Study Reports CSR for EMEA, WHO, SAHPRA. TGA, US- FDA, Costa Rica, others regulatory and Appendices and formats as per projects
Exposure of Waters HPLC, Dissolution, GC and other Instruments with AMV, RM, PM, FP product analysis Handling of QMS related Activities Exposure of various instruments/ software like Empower 3, LIMS and other softwares
Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.
To visit medical professionals and promote company products as per the company strategy by generating prescriptions. To visit chemists and Stockists and ensure availability of the products.
Preparation of IPQA SOPs, IPQA Checks, AQL, Line Clearance, Review of BPR, Audit and Compliance, Sampling of API & Drug Product, Document and Data Control, Control Sample Management.
Candidate should have experience in IPQA activities for Manufacturing. Packing area and Warehouse for Sterile Facility. Candidate should have experience in Sterile facility and good competency require in Qualification & Validation activities
Gland Pharma is the worlds leading player in Injectables Formulation and Manufacturing. It is also into API and Intermediates research and manufacturing. Gland Pharma is present in sterile injectables, oncology and ophthalmic segments, and focus on complex injectables including NCE-1s, First-to-File products and 505b2 filings.
Post : Research Associate / Senior Research Associate