Teva is hiring
Associate Director -Analytical
Location: Ambernath, Mumbai
Qualifications
M.Sc. with 15-20 Years
M. Pharm. with 14-18 Years
Ph.D. with 10-15 Years
Interested candidates send me updated CV
Email id: apeksha.shinde@teva.co.in
Considering Sr manager level applications only.
Job Description
- Exposure to work with Global Operations Site is advantages
- Ensure lab compliance with respect to GLP/GMP, 21CFR Part 11 & Data Integrity.
- Evaluation, Assessment & confirmation of Nitrosamine Impurities.
- Evaluation, Assessment & confirmation of Genotoxic Impurities.
- Evaluation, Assessment & confirmation of Elemental Impurities
- Evaluation, Assessment & confirmation of Residual Solvents USP<467> compliance.
- Qualify Vendors for Active Pharmaceutical Ingredients, Excipients, Packaging Materials. etc.
- Ensure Product Development of Solid oral dosage i.e. Dissolution, Assay, CU, BU and Related substances etc.
- Ensure analysis of samples received from Formulation department (samples include in-process, finished product, pre-formulation study samples and stability samples etc.).
- Ensure & guide analytical method development, in-process samples and finished products.
- Ensure analytical method transfer at various Global Operation Sites.
- Prepare analytical laboratory budget- forecast & planning Capex & Review Budget.
- Ensure effective coordination between cross functions to completion of projects.
- To review analytical raw data/records, protocols, reports, specifications, standard operating procedures and other analytical documents.
- Ensure Trouble shooting of analytical instruments for difficulties faced during day-to-day operations.
- Ensure Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc.
- To co-ordinate with approved contract testing laboratory for test and analysis of samples, the facilities for which are unavailable in-house.
- Literature Search for development of analytical methods.
- Preparation of regulatory documents like Photo-stability, comparative dissolution profile report, residual solvents assessment report, elemental impurity assessment report and nitrosamines impurity assessment reports.
- To ensure safe practices are followed during the execution of activities and strict adherence to the EHS systems of the site.
- Accountability for the smooth functioning of Analytical Section, provides leadership, supervises & Manages large team size of Researchers /or Junior Managers.
- Accountable for performance and results of multiple related units.
- Develops departmental plans, including business, production and/or organizational priorities.
- Decisions are guided by resource availability and functional objectives.
- Hiring process participation, performance management of up to 20 employees.
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