QC Associate

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!

Job Description

They were working independently under the supervision of the QC Laboratory Supervisor. The incumbent having advanced knowledge of analytical chemistry (USP/NF, BP/EP) and GMP/cGMP testing requirements, coordinates audits and performs release activities associated with all analytical testing (Raw Materials, Finished Products, Stability, Packaging Components, Microbiology) served in the Quality Control Laboratory. In addition, the incumbent will be required to audit instrument calibration records.

Duties and responsibilities include but are not limited to:

• Responsible for the final analytical release assessment of raw materials, finished products, in-process, packaging components, Technical Services, Process Validation, and stability samples
• Reviews and checks analytical reports, operational/instrumental parameters, formulae, calculations, chromatograms, and printouts related to raw materials, finished products, stability, packaging component, and microbiological testing by ensuring that work by the lab has been carried out by specifications, analytical methodology (compendia and in-house), standard operating procedures, training and qualification programs and the GMP/cgmps.
• Coordinates and ensures that all the applicable documentation from multiple specialized testing groups within QC related to a project's testing is compiled and organized before rule before filing the analytical documentation.
• Responsible for auditing instrumentation calibration records by approved standard operating procedures and training and qualification programs.
• Responsible for electronic signature audit entries in the Laboratory Information Management System (LIMS), Empower, Trackwise, and SAP.
• Audits all electronic records in LIMS, Empower, and Trackwise before authorizing components in LIMS.
• Responsible for Data Integrity Audits on analytical instruments in the QC Laboratory.

Qualifications

• Minimum College or University Degree in Chemistry or a related field.

• Advanced knowledge of technical requirements per compendia (USP/NF, BP/EP), in-house methods, and general QC laboratory procedures and investigations.

• Knowledgeable in GMP/cGMP regulations as they apply to laboratories.

-Advanced knowledge of analytical instrumentation (ex. HPLC, UPLC, GC, Dissolution), CDS (Chromatography Data System) -Laboratory Information Managements system (LIMS), Empower, SAP, Laboratory Instruments.

• Product Knowledge, Laboratory compliance standards

Function

Sub Function

Reports To

In process of validation

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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.