About The Role

Job Description

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 GMP guidelines
• 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
• Certify batches and finished products to be released by Takeda
• 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
• 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
• 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

What You Bring To Takeda

• Eligibility to act as Qualified Person in line with local and EU directives 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
• Thorough understanding of quality systems and cGMPs
• Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms
• 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)
• Reading, understanding, speaking and writing in technical and legal English
• Other essential technical skills good experience in conducting audits, ability to eveluation of data
• Interpersonal and professional skills to interact with external contract manufacturers/suppliers/test labs representing Taked
• 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
• Working style ability to priortize, very good organized, attention to details, flexible and comfortable with ambiguity in a “start-up” environment

• 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
• Medical checkups
• Free vaccination program
• Fitness Center

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.

Locations

AUT - Wien - Industriestrasse 67

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time