Manager QP

We Are Teva

The Opportunity

How You’ll Spend Your Day

• Take personal responsibility for releasing products to market in accordance with applicable licence and regulatory requirements.


• 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

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Teva’s Equal Employment Opportunity Commitment