Job at a glance
## We Are Teva We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration.
You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. ## Our Team, Your Impact This section is where we attract the attention of potential candidates and sell the role. How has the role come about? What makes it appealing? What are the key responsibilities? How is the role better with Teva than with another company? Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we’re in it together, and we make work fulfilling.
## How You’ll Spend Your Day * Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s. * Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres. * Review of Instrument/Equipment Qualification records.
* Review of BMR. * Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance. * Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system * Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
* Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products * Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites ## Your Skills and Experience * 2 to 8 years of experience in QA / QC function in the pharmaceutical industry * Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences * Basic knowledge on worldwide cGxP regulations * Good English language skills, other language skills could be helpful * Good communication skills * Basic knowledge of Computerised Systems.
Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage * Basic understanding of manufacturing, QC and Contract manufacturing processes * Engagement to drive improvements and ability to manage complexity * Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) & Stability Studies.
* Hands-on experience on Review of Instrument/Equipment qualification records. * Basic knowledge / hands on experience of review of BMR. * Basic knowledge / hands on experience on Product Quality Reviews. ## Also Good to Have ## Salary Range ## How We’ll Take Care of You At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work.
This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career