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Manager QP
Teva Pharmaceuticals
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
Posted 5 days ago
About this role
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. The Opportunity We would like to invite applications for the role of Manager, Qualified Person (QP) at our Waterford site. As Manager, Qualified Person, you will be responsible for ensuring that all products released for commercial purposes comply with the requirements of the Marketing Authorisation and have been manufactured according to the principles of GMP, as set out in Directive 2001/83/EC . How You’ll Spend Your Day + Take personal responsibility for releasing products to market in accordance with applicable licence and regulatory requirements. + People Management/Supervision of team of Quality Officers/Complaint Investigators + Ensure that all stages in the manufacture, testing and packaging of products comply with cGMP, cGLP, regulatory and licence requirements. + Ensure that all batch-related documentation is completed and endorsed by appropriately trained personnel. + Review and release batches in line with shipment schedules, ensuring compliance with all applicable regulatory requirements. + Approve or reject product batches within your assigned area of authority. + Review and approve investigations into incidents and Out-of-Specification results before batch release. + Define batch-investigation requirements and responsibilities. + Ensure that principal manufacturing and testing processes have been appropriately validated. + Confirm that all necessary checks and tests have been performed, taking account of production conditions and manufacturing records. + Ensure that planned changes or deviations in manufacturing or Quality Control are appropriately reported and assessed before product release, including notification to or approval by the HPRA where required. + Ensure that any additional sampling, inspections, tests or checks required to address planned changes or deviations are completed or initiated. + Act as QP for the release of product types for which you possess the relevant experience and knowledge. + Coordinate or contribute to product-recall decisions as required. + Collaborate with internal and external stakeholders to resolve quality, product and release-related issues. + Identify and recommend process improvements as part of the company’s overall Continuous Improvement programme. Your Skills and Experience Are you... + A qualified Pharmacist, a graduate of a Diploma in Pharmaceutical Manufacturing Technology, or a holder of equivalent Qualified Person status as defined by E.C. Directive 2001/83/EC? Do you have... + A minimum of five years’ experience within the pharmaceutical industry in a QA, QC or Compliance role? + Excellent knowledge of applicable Irish, European and FDA regulations, licences and sources of regulatory information? + Strong report-writing and analytical skills? + Excellent attention to detail and a strong level of quality awareness? + The ability to identify key issues, analyse information from different sources and understand cause-and-effect relationships? + Strong collaboration, decision-making and problem-solving skills? + The ability to make timely, well-informed decisions and take appropriate action? + A proactive approach to identifying improvements and resolving quality-related issues? + Knowledge of relevant company procedures, policies and standards, including SAP? + Relevant experience and product knowledge to act as a QP for the applicable product types? 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, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. Already Working @Teva? Make sure to apply through our internal career site on Twist—your one-stop shop for career development Teva’s 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. EOE including disability/veteran