Imp Qualified Person

vor 1 Woche

Wien, Österreich Takeda Pharmaceutical Vollzeit

**About the role**:
In this role you will act as Qualified Person (QP) in accordance with applicable regulations for Investigational Medicinal Products (IMPs) in the Pharmaceutical Science Quality Europe group of the global Pharmaceutical Science & Device Quality organization of Takeda.

**How you will contribute**:

- Perform QP certification activities with responsibility for Takeda IMPs in the fields of biologics, small molecules and plasma derived products in accordance with their Clinical Trial Authorization (CTA), their IMP Dossier and their Manufacturing Authorizations and the principles and guidelines of cGMP as laid down in Directive 2017/1572 and Delegated Regulation 2017/1569 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/workload with different key stakeholders to ensure the quality of investigational medicinal product and compliance with cGMP.
- Employ GMP QA expertise and principles during the development, manufacturing, testing, packaging and release of clinical trial material.
- Be responsible for the successful, timely completion of goals and objectives, which will strengthen the Takeda R&D Quality organization.
- Certify batches and finished products to be released by Takeda in the EC/EEA have been manufactured and checked in accordance with the CTA, GMP, Product Specification File and legal requirements as set out in Article 51 of directive 2001/83 and Article 61 of CTR 536/2014. to assure drug product, documentation, and data related to manufacturing, packaging, labelling, and testing of IMPs are compliant with all cGMP, SOP, CTA, and regulatory requirements.
- Batch documentation review and release activities per Takeda quality systems; (to be knowledgeable about the products supplied for clinical trials, to provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and regulatory requirements, to review and approve Master and Executed Batch Records and Packaging Labels, to ensure that all required batch documentation is obtained from contract manufacturer/suppliers to enable the release of product, to actively participate in project meetings as required)
- Effectively liaise with contractor manufacturers/suppliers regarding technical information and queries,
- Ensure that deviations and OOX (OOT, OOL,..) investigations are adequately investigated and documented and guarantee clinical complaints are adequately investigated and reported
- Review and approve analytical test methods protocols, Master Batch records, executed batch records, reports, specification documents, method qualifications/validations, and stability study plans/reports as they pertain to Clinical Trial Materials.
- Review regulatory submissions, drafting & coordinating Quality Agreements, documentation control
- Supporting the external auditing program, by participating in external audits as SME to assure compliance with GMPs, regulatory filings, FDA, EU and other applicable regulatory guidelines as well as building and maintaining strong working relationships with Clinical CMOs
- Maintain an up-to-date knowledge of the regulatory environment as it pertains to position and responsibilities.

**What you bring to Takeda**:

- Eligibility to act as Qualified Person in line with local and EU directives (QP certification of biological, Plasma derived and small molecule development products) and master’s degree in chemistry, biology, pharmacy or a related discipline
- At least 3 years experience working in an Quality Assurance role or in an Quality Assurance 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
- QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with global GMP and regulatory requirements
- Be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs, IMPDs and clinical trial authorizations, evaluating of (trending) data
- Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
- Exchange and communication with the following internal stakeholders: Global and Local Quality Assurance, Global Clinical Supply Chain, Regulatory Affairs, Pharmaceutical Science, Pharmaceutical and Analytical Development, Quality Control, Process Development
- Exchange and communication with external stakeholders: Contract Manufacturers, Contract Distributors, Contract Laboratories
- Reading, understanding, speaking and writing in technical and legal English
- Ability to work during routine business hours bu

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