Qualified Person (QP)Apply Now Job ID R0002564 Date posted 06/11/2018 Location:Dublin, Ireland
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Qualified Person in our Bray office in Co. Wicklow.
Takeda is a global pharmaceutical leader with more than 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
For the Manufacturing licence, act as a Qualified Person in accordance with EU Directive 2001/83/EC.
The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organisational, supervisory, technical writing and investigation skills are required.
- For the Manufacturing license, act as one of the Company’s Qualified Persons in accordance with EU Directive 2001/83/EC.
- To act as the QP for one of the production plants.
- Role of QP to include
- Direct contact with relevant production Coordinator on GMP issues.
- Cooperation with Production to ensure continuous improvement
- Provide details on corrective actions required for batch deviations
- Assist in the implementation of Quality Systems within production to ensure compliance with GMP
- Provide regular feedback to other QP’s on main issues for relevant production plant
- To act as QA representative on major projects as required.
- Communication / liaison with other departments.
- Participate fully in any cross-functional training initiatives.
- Participate in the vendor audit program.
- Participate in the self-inspection programme.
- To assist in audit preparation for regulatory and customer audits and to act as a member of the audit team as required.
- Maintenance of the Quality Systems within Takeda.
EDUCATIONAL REQUIREMENTS/RELEVANT EXPERIENCE:
- Possesses suitable educational background that meets the requirements of Article 49 of Directive 2001/83/EC.
- Have a minimum of five years’ experience in the Pharmaceutical Industry in a QA role.
- QP experience in solid oral dosage manufacture and/or packaging is preferable
- Good organizational, investigational & technical writing skills are required
- Be a self starter who is motivated & innovative
What Takeda Can Offer You
To further support and inspire our employees, our benefits include: To further support and inspire our employees, our benefits include: Talent & Development Programme, Flexibility, Occupational Health & Wellness Programme, Company Events, Health Insurance, Pension, Paid Maternity/Paternity Leave, Educational Assistance Programme, Performance Related Bonus, Zero Absence Award, Onsite Parking, and Onsite Canteen.
Empowering Our People to Shine
Takeda Ireland Limited is an Equal Opportunities Employer