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.
Experienced in qualification documents preparation i.e. protocol preparation. Risk assessment, technical documents review and execution. Hands on experience on QMS - investigation, change control, impact assessment: Drafting and review.
Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia. Prepare responses to deficiency letters received from various agencies.
Masters in Life Sciences, Biochemistry, Bio technology, Molecular Biology with at least 2 years of research experience
Research Experience in Molecular Biology including PCR, RT-PCR. Cell Culture, Invitro Cell based Assays, Flow Cytometry Techniques, Immunological Techniques. Candidates having Publications in Peer Reviewed Journals will be given preferences
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.
Matriculation or equivalent and should be a Registered Pharmacist under the Pharmacy Act, 1941. The maximum age of the applicant should not exceed 56 years on the closing date of the receipt of the application.
M.Sc. in Life Sciences with four years experience in Research and Development OR M.Pharm. in Pharmacology with two years experience in R&D OR Ph.D. in Life Sciences, Pharmacology