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 but be flexible to cover global business hours ; ability to travel will be approx. 10%
Other essential technical skills: good experience in conducting audits, ability to eveluation of data and very good computer literycy,
Interpersonal and professional skills to interact with external contract manufacturers/suppliers/test labs representing Taked
Essential soft skills: be able to work in global teams with global products, influencing skills, good communication style, decisions making ability, problem solving ability as well as good analytical mindset (critical thinking/evaluation of process problems)
Working style: ability to priortize, very good organized, attention to details, flexible and comfortable with ambiguity in a “start-up” environment , ability to multi-task in an environment with changing priorities and to work independently as well as very strong work ethic
What Takeda can offer you:
A competitive remuneration package with a minimum salary of € 4.751,92 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
Work @ home depending on the position / department
Comprehensive training programs
In-house job rotation program
In-house Canteen with discounts or meal vouchers
Works council (events, festivals, shopping vouchers, etc.)
Employee Referral Program
Employee Recognition Program
Takeda Resource Groups
Free vaccination program
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
AUT - Wien - Industriestrasse 67
Fixed Term (Fixed Term)