Job Title : Quality Assurance Associate (m/f/d)Location : HoofddorpCompany : Takeda PharmaceuticalSalary : Open Date : 2023-02-04Close Date : 2023-06-04
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Job DescriptionPeople First - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. Our people are the heart of Takeda.
We are looking for a
Quality Assurance Associate (m/f/d)
in part-time for our location Hoofddrop, The Netherlands.
The purpose of this position is to carry out the role of (deputy) Responsible Person for Takeda Nederland BV regarding Good Distribution Practice as described in the Commission Guideline 2013/C 343/01, chapter 2.2 Responsible Person. The person will report to the Head of QA Benelux.
Your tasks in detail:
- Ensuring that a quality management system is implemented and maintained (incl. quality risk management, corrective and preventative actions (CAPAs) to address deviations, change control, measurement of performance indicators and management review)
- Ensuring that initial and continuous training programs are implemented and maintained
- Coordinating and promptly performing any recall operations for Takeda’s medicinal products; The (d-)RP is sufficiently supported by other functions to handle all the aspects of the recalls with the appropriate degree of urgency
- Ensuring that suppliers and customers are approved, and carry out due diligence checks
- Ensuring that relevant customer complaints are dealt with effectively
- Approving any subcontracted activities which may impact on GDP
- Ensuring that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place
- Keeping appropriate records of any delegated duties
- Deciding on the final disposition of returned, rejected, recalled, or falsified products
- Approving any returns to saleable stock
- Ensuring that any additional requirements imposed on certain products by national law are adhered to
- The (d-)RP acts as contact person for the Dutch Health authority
- The (d-)RP works closely together with the DSO, Medical Director, Financial Director and other relevant stakeholders
- The RP should carry out his/her duties in such a way as to ensure that Takeda Nederland by can demonstrate GDP compliance and that public service obligations are met
Your profile:
- University Degree (MSc) in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology or equivalent
- GDP training courses, demonstrable by certificates
- Specific knowledge with respect to wholesale activities of human medicines
- At least 2 years of practical experience in storage and distribution activities of medicines
- Experience in a similar position at a local affiliate in the pharmaceutical industry is an advantage
- Adequate knowledge of relevant national and international laws, regulations and guidelines, including (among other things) Dutch medicines law, opium law, Commission Guideline 2013/C 343/01 Good Distribution Practice, Directive 2001/83/EC Medicinal products for human use
- Keeping up-to-date knowledge on developments at the Dutch Health Inspectorate
- Fluent in Dutch and good language skills in English
- Good organizing, planning, analytical, communication and negotiation skills
- Strong personality, perseverance, accuracy, integrity, responsibility, pro-activity
- Ability to clearly present cases and provide clear argumentation for any decision making to internal/external stakeholders
Empowering our people to shine
At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world. Learn more at takedajobs.com.
Diversity, Equity and Inclusion
Takeda is committed to foster diversity, equity and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age or disability.
If you are interested in this opportunity, we look forward to receiving your application via our online tool! Please apply with a CV in English.
For further questions, please contact: Jennifer Kriedemann | Talent Acquisition Partner BU EUCAN | Email: [email protected]
Locations Hoofddorp, Netherlands Worker Type Employee Worker Sub-Type Regular Time Type Part time