Alembic Pharmaceuticals is looking for competent personnel to be an integral part of our Central Validation Lab Dept. for our API plant-based at Karakhadi, Vadodara-Gujarat.
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.
Title: Assistant Manager- Central Validation Lab (API)
Qualification: B. Pharma, M.Pharma/B.Sc., M.Sc.
Experience: 9 – 14 years
Salary: Not Disclosed
Skills: QC, Team Supervision, team leader, Analytical Method Validation, SOP, Audit Compliance, Method Validation, Data Management, Wet Chemistry, Method Transfer, Analytical Techniques
1. Responsible for planning of analytical activities in Central Validation laboratory and compliance as per existing SOPs, safety, and cGLP.
2. Ensuring calibration and qualification of equipment and instruments is done as per Calibration planner.
3. To assist in the investigation of Method Validation and method transfer laboratory results and documentation.
4. To ensure the procurement of laboratory items as and when required.
5. Training and evaluation of staff on key areas of work involving wet chemistry, instrumentation and documentation, and principles of cGMP/cGLP.
6. To ensure in method transfer of analytical techniques from R & D to API QC and from API QC to Formulation QC for new products.
7. To ensure analytical method validation activity.
8. To ensure completion of cut-off studies activity to fulfill regulatory requirements.
9. Ensure periodic update of master documents like SOP, Specification, and STPs.
10. Review and updating of specifications and test methods through DMS to ensure compliance with statutory and Company standards.
11. Review and approval of method validation, method verification, and method transfer protocols & reports of CVL documents.
12. To ensure compliance in activity related to user management, data management, and audit trial for all the electronic records.
13. To ensure Audit Compliance.
14. Any other assignment given by the Reporting Head or Department Head.