To perform investigation for Deviation, OOS, OOT observed at plant.Preferably to have regulated market Science based scale up factor based Tech transfer experience.
Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non-conforming samples, CAPAs, data evaluation and reporting.
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
Candidates who have passed Diploma in Pharmacy course from an institution approved by the Pharmacy Council of India under section 12 of the Pharmacy Act, 1948 can register for the Diploma in Pharmacy Exit Examination.
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.
AstraZeneca Fasenra benralizumab has been approved in China by the country National Medical Products Association NMPA for the maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma.
In a bid to decriminalise and rationalise offences to further enhance trust-based governance for ease of living and doing business, the Jan Vishwas (Amendment of Provisions) Act, 2023 was published in the Gazette of India, Extraordinary, Part II – Section 1, No. 21 on the 11th August, 2023. This Act has altogether amended 42 Central Acts including the Drugs and Cosmetics Act, 1940 (XXIII of 1940) [at Sl. No. 6 in The Schedule].