This individual will act as Qualified Person (QP) in accordance with applicable regulations for Investigational Medicinal Products (IMPs) in the Pharmacieutical Science Quality Europe sub-group of Takeda.
Your (new) Opportunity:
- Perform QP certification activities with responsibility for Takeda IMPs in accordance with their Clinical Trial Authorization (CTA), their IMP Dossier and their Manufacturing Authorizations and the principles and guidelines of GMP as laid down in Directive 2003/94/EC and in accordance with principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products
- provide QA/QP support for work performed at contract manufacturers and analytical laboratories, and coordinate priorities and workload with key stakeholders
- responsible for the successful, timely completion of goals and objectives, which will strengthen the Takeda R&D Quality organization
- certify that batches and finished products to be released by Takeda in the EC/EEA have been manufactured and checked in accordance with the CT, GMP, Product Specification File and legal requirements as set out in Article 51 of directive 2001/83
- assure drug product, documentation and data related to manufacturing, packaging, labelling and testing of IMPs are compliant with all GMP, SOP, CTA, and regulatory requirements
- Batch documentation review and release activities per Takeda quality systems: provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and regulatory requirements; review and approve Master Batch Records and Packaging Labels; actively participate in project meetings as required; be knowledgeable about the products supplied for clinical trials; ensure that all required batch documentation is obtained from contractor manufacturer/suppliers to enable the release of product
- effectively liaise with contractor manufacturers/suppliers regarding technical information and queries
- Ensure that deviations and OOX (OOT, OOL, ..) investigations are adequately investigated and documented; ensure clinical complaints are adequately investigated and reported
- Review and approve analytical test methods protocols, Master Batch records, executed batch records, reports, specifications, method qualifications/validations, and stability studies reports as they pertain to Clinical Trial Materials
- Review regulatory submissions; drafting & coordinating Quality Agreements
- participate in external audits as SME to assure compliance with GMPs, regulatory filings, FDA, EU and other applicable regulatory guidelines
- Maintain an up-to-date knowledge of the regulatory environment as it pertains to position and responsibilities
Your Skills and Qualifications:
- Eligibility to act as Qualified Person in line with local and EU directives
- Master's degree or PhD in chemistry, biology, pharmacy or a related discipline
- At least 9-12 years experience working in Quality Assurance role or in a QA environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred)
- Thorough understanding of quality systems and cGMPs
- Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms
- Must be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs, IMPDs and clinical trial authorizations
- Interpersonal skills and professional skills to interact with external contract manufacturers/supplier/test labs, representing Takeda
- Must be able to prioritize and multitask in a stressful environment
- Must be able to read, understand, speak and write technically and legibly in German and English
- Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
- Experience conducting audits
- Attention to detail
- Critical thinking/ evaluation of process problems; good analytical mindset, problem solving
- Decision making ability
- Inter-personal and influencing skills
- Organized, articulate, computer literate
- Data trending and evaluation
- Strong work ethic
- Ability to work during routine business hours but be flexible to cover global business hours
- Ability to travel approx. 10%
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application!
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.