The Quality Control Analytical Laboratory is responsible for all analytical testing to support the production Cytotoxic and Inhalation drug products. The laboratory executes a wide variety of analytical test package to test APIs, excipients, packaging materials and drug products for release and stability purposes. Also transfer, validation and verification of analytical methods for testing of new drug products are performed in the laboratory. As a result of the increase of products to be tested the Quality Control Analytical Laboratory is searching for.
Routine Testing of the raw materials, primary and printed packaging materials & finished products, stability samples and in-process control samples according to SOP and as per the committed time lines.
Handle quality management system like Deviations, Out of specification results (Phase 1 investigation), Out of trend results in stability as well as in released products,
Writing, review and approval or reject of test results
Act as team lead in absence of Group leader
Maintain adherence to corporate policies and appropriate regulations through actions and decisions
Active participation in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions
First-line Troubleshooting of laboratory equipment
Active participation in changes or act as change owner as part of continuous improvement.
Bachelor degree in analytical chemistry/pharmacy or equivalent experience
Knowledge and familiarity with the use of Pharmacopoeia methods
A strong analytical oriented mindset.
Experience with working in a pharmaceutical environment
Experience with development/validation or verification of analytical methods for complex drug products like liposomal or protein coated drugs
Experience with analytical techniques like, UPLC/HPLC, TOC, PSD, etc.
Good knowledge of Pharmaceutical quality systems and production processes
Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection , US-FDA, ANVlSA
Strong can-do mentality
Competence to act as team lead in absence of a Group leader
Manufacturing Quality Control
In process of validation
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