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
To monitor routine GLP activities in lab, involves in planning and execution of GLP related activities like preparation of Calibration planner, Preventive Maintenance planner, Preparation and review of SOP, STP, AWR.
Completes basic job-related responsibilities, including time sheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives, projects as requested by management
Responsible for Safety Data Exchange Agreement SDEA management. Responsible for preparation and maintenance of Pharmacovigilance System Master File PSMF