Quality Compliance Specialist: Technical Writer (f/m/x), Hybrid




Quality Compliance Specialist: Technical Writer (f/m/x), Hybrid




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Job Description

About the role:

Are you interested in a position that combines learning a lot about the manufacturing processes on site and working in teams making sure that submissions are written accurately and on time? Are you a well organized and responsible person, who will represent the site to deliver high quality submissions for our patients? Then make sure to apply, we are looking forward to it.

How you will contribute:

  • Preparation, coordination and update of production documentation for CMC regulatory submissions

    • Preparation and review of documentation related to chapters describing production, processes and facilities & equipment, process validation and equipment qualification

    • Coordination between site-related functions (Production, Validation, Quality etc.), global functions (e.g. PQLs) and Regulatory Affairs

    • Response to questions from authorities related to above listed chapters

  • Preparation and maintenance of Process Reference documents (for the assessment of manufacturing deviations according to licenses) and corresponding procedure

  • Additional support for other chapters in CMC regulatory submissions if necessary

  • Support of GMP renewals/facility registration requests

  • Quality review and content verification of submission documents

  • Point of contact for the Vienna site during alignment meetings with Regulatory Affairs (different time zones)

What you bring to Takeda:

  • Graduated from a technical, chemical or biological college or university

  • At least 2 years practical experience in pharmaceutical industry (from areas such as quality assurance, validation, manufacturing etc.)

  • Understanding of the quality requirements in the areas of manufacturing, manufacturing science and validation

  • Knowledge of applicable regulations and laws for biological products, such as FDA CFR, EU GMP beneficial

  • Personal features: responsibility, accuracy, strong analytical skills, organizational skills, team player

  • Technical skills and affinity for IT

  • Fluent in English and German and strong communications skills

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 3.909,67 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

  • 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.


AUT - Wien - Industriestrasse 67

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Time Type

Full time