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.
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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
Alembic Pharmaceuticals is looking for competent personnel to be a part of the MS&T Team at formulation Injectable plant-based at Karakhadi, Vadodara – Gujarat.
Position: Manager/Sr Manager – Technology Transfer (MS&T – Injectable)
Location: Vadodara, Gujarat, India
- Should have major experience in handling injectable dosages.
- Responsible for Technology transfer, execution, and monitoring of R&D and site transfer products.
- Prepare and review technical data, identifying and evaluating CPPs, stability data technical documents.
- Finalize manufacturing Process and Parameters/ CPPs for Scale-up, Exhibit, Process Validation batches, and Commercial batches.
- Reviewing and providing feedback/ technical/ scientific support on project deliverables i.e. remediation initiatives, plans, reports, etc.
- Coordinate with internal departments like purchase, Analytical R&D, Production, Quality Control, Regulatory Affairs, Quality Assurance, Project Management, Engineering, etc. for seamless Technology Transfer through the New Product Introduction procedure.
- Coordinator with manufacturing to meet the production schedule, ensure commercial supply, and uphold the quality standards.
- Review and preparation of CTD, Batch Manufacturing Record, New Product Forms, etc.
- Partnering with manufacturing to meet the production schedule, ensure commercial supply, and uphold the quality standard.
- Support to Regulatory affairs for ANDA filing activity and respond to regulatory queries.
- Assisting in documenting changes/ updates to the manufacturing process and working with manufacturing, engineering, and validation to implement those changes.
Qualification: B.Pharma/B.Sc, MS/M.Sc
Experience: 8-10 Years
Ms. Sweety Chauhan
email@example.com, firstname.lastname@example.org, email@example.com
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