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
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.
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.
Collaboration with R&D and other stakeholders to enable timely filing and review of documents for EU, UK, CA, AUS for solid oral and topical dosage forms RA strategy in collaboration with partners with focus on cost implications.