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
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Senior Regulatory Affairs Associate (Labelling)
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
Experience in IPQA, Process & Cleaning Validation, Media fill Air- flow study, Continuous process verification, Batch release, Finish product sampling,Shop floor activities
To perform investigation for Deviation, OOS, OOT observed at plant.Preferably to have regulated market Science based scale up factor based Tech transfer experience.