Job Description

Associate Director - Analytical R&D Unit

Date: Jan 13, 2023



Location: Ambernath, India, 421506



Company: Teva Pharmaceuticals



Job Id: 44066

Who are we?

Teva is a global pharmaceutical leader and the world\'s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world\'s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we\'ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

• 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.

Qualifications

M.Sc. with 15-20 Years M. Pharm. with 14-18 Years Ph.D. with 10-15 Years

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

Already Working @TEVA?

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Teva\xe2\x80\x99s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva\'s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.