Manager QP
Waterford, Ireland, X91
Who We Are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
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 being released for commercial purposes comply with the requirements of the Marketing Authorisation and have been manufactured according to the principles of GMP as per Directive 2003/94/EC.
How You’ll Spend Your Day
- Ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the cGMP/cGLP/Regulatory and licence requirements
- Closely manage all batch related documentation to ensure completion and endorsement through relevant trained personnel.
- Review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements.
- Identify and make recommendations for improvements to the process within the overall Continuous Improvement process of the Company.
- Outlining batch investigation requirements and responsibilities.
- Releasing batches as per scheduled shipment date (where possible).
- Ensure the principal manufacturing and testing processes have been validated.
- All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records.
- Any planned changes or deviations in manufacturing or QC have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to and approval by the HPRA..
- Any additional sampling, inspection, tests and checks have been carried out or initiated as appropriate to cover planned changes or deviations.
Your Experience And Qualifications
Are you….
- Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent “Qualified Person” status as defined by E.C. Directive 2001/83
Do you have….
- Proven experience within the Pharmaceutical industry in a leading QA/QC/Compliance role.
- Excellent knowledge of regulations and sources of regulatory information.
- Knowledge of Report Writing
- Experience of Accomplishing tasks through concern for all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; maintaining watchfulness over a period of time.
- Experience of Securing relevant information and identifying key issues and relationships from a base of information; relating and comparing data from different sources; cause-effect relationships.
- Knowledge of company procedures, policy and standards (SAP)
- Authority to approve/reject product batches
- Experience of Review / approval of investigations into incidents before releasing a batch
- Review / approval of Out-of-Specification investigations before releasing a batch
- Experience as QP for release only of product types for which they possess the relevant experience or knowledge
- Experience of Co-ordinating / being involved in recall decision
Reports To
Joanne Bourke
Director, Site QA
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
#TJ If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva designs eligibility to empower and enable employees to manage their careers internally and provides an easy and smooth process to view and apply. To be considered for an open internally posted position, an employee must:
- Be a current employee of Teva
- Meet the basic requirements for the job
- Have received a rating not lower than “Successful” on their most recent performance review and must not currently be on a performance improvement plan
- Apply to the posted requisition within the allotted time frame
- Have been in their current position for a minimum tenure of twelve (12) months
- Unless explicitly stated in the job description, no company sponsored work authorisation or relocation assistance should be assumed.
Deadline for internal applications will close on Thursday 27th November 2025
Teva’s Equal Employment Opportunity Commitment