Quality Assurance Lead und Auditor (f/m/d), fixed term for 2 years, Hybrid

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The main responsibility is maintaining and supporting the quality oversight of the GLP QA program of Takeda´s GLP Test Facility in Vienna and the Quality Control testing activities associated with Adventitious Agent Testing (AAT) under GMP.

This role includes leading internal and external (supplier) quality audits to assess quality management systems, adherence to applicable regulations/procedures and appropriateness for use by quality standards.

• Provide GLP quality oversight and ensure a state of compliance for internal GLP activities within the GLP Test Facility Vienna.

• Perform protocol, study phase, raw data, amendment and final report reviews and audits of non-clinical studies conducted in compliance with international and domestic GLP and OECD GLP regulations (in-house and multi-site as applicable)

• Perform internal process and facility based audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance.

• Quality Assurance function for method qualification (AAT and serology testing QC lab)

• Participate in regulatory inspections and inspection readiness activities

• Maintain GLP training program to ensure that personnel are appropriately trained to carry out GLP

• Review and audit documents, SOPs, computerized systems, and in support of GXP regulated activities for compliance

• Bachelors degree in a scientific field (or a combination of education and experience)

• Minimum 5-7 years of experience in GLP, GMP compliance/ QA in a pharmaceutical or biotech industry

• Previous work experience in internal/ external domestic and international GXP auditing required

• Experience in training initiatives

• Good knowledge of international regulatory requirements and industry guidelines for global GXP

• Ability to identify issues and offer solutions in a pragmatic way

• General knowledge of drug development process

• Excellent written and verbal communication skills in German and English

A competitive remuneration package with a minimum salary of € 5.538,85 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

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.

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.