Alembic Pharmaceuticals Limited, with an established presence in the Indian pharma industry has a proud, historical track record going back one hundred years. With a turnover in excess of Rs. 3000 crores today, Alembic Pharmaceuticals Limited is one of the leading API & Formulations manufacturing and marketing pharmaceutical company. We continue to enjoy leadership positions in antibiotics, anti-infective, anti-cough, and also have a significant worldwide presence in specialty therapeutic areas such as cardiology, neurology, diabetology, etc. We have newly setup plants of Oncology, General Injectable and Dermaceuticals. Upcoming plans of General Oral Solid Dosage at Jarad, near Vadodara. Alembic is having manufacturing facilities at Vadodara, Panelav , Karkhadi, Jarod in Gujarat, and Domestic manufacturing of Formulations at Sikkim. Gujarat based facilities are approved by the US FDA, EDQM, TGA, MHRA, and MCC. Alembic Research Center at Vadodara (ARC) and AG Research Center at Hyderabad a world-class research organization provides a comprehensive range of services in the areas of synthetic chemistry, formulations, NDDS, Oncology as also preclinical pharmacology, bioequivalence / bio-analytical studies, etc. ARC & AG Research, designed to state-of-the-art GLP standards with more than 350 scientists working on the latest technology and systems. Our current employee strength is in excess of 8000 across the country. A continuously expanding organization, we invite dynamic, result-oriented competent personnel to join us across various functions.
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Designation: Clinical Affairs F&D
Location: Vadodara
Job Description:
- Evaluation and management of external/in-house BE center – contract service provider for BA/BE and Clinical studies.
- To conduct a literature search to gather the scientific information of the product for the BE strategy finalization.
- Designing & review of the protocol (for various dosage forms like IR, MR, Sublingual/ODT and Suppositories, etc.) for various types of bioequivalence study like food effect study, steady-state, partial replicate/replicate studies for Solid orals and adhesion & irritation studies for Transdermal products.
- Review of protocols, reports, and study-related documents, maintaining the project files and records as per regulatory requirements like USFDA, MCC, EMEA, ANVISA, and other regulatory authorities.
- Well versed with regulatory requirement USFDA, EMEA, ANVISA, Health Canada, DCGI, CDSCO w.r.t BA/BE, and clinical studies
- Extensive experience with the conduct of bioanalytical and PK studies
- Extensive knowledge with FDA, EMA, and ICH guidelines and extensive knowledge of good laboratory practices and good clinical practices
- Extensive knowledge of Watson LIMS (or equivalent systems) and barcode application
Qualification: B.Pharma, M.Pharma
Experience: 5-9 Years
Salary: Negotiable
Contact Details:
talent@alembic.co.in, qualityform@alembic.co.in
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