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
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)
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.
Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia. Prepare responses to deficiency letters received from various agencies.
Looking for suitable candidates for its Formulation facility at Dahej, Bharuch, Gujarat. Experience of FG Testing and Stability, HPLC, Dissolution, Gas chromatography, AMV and GLP section.