Senior Specialist Quality Assurance

**Job Description**:
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are currently looking for a **Senior Specialist** **Quality Assurance (m/w/d)** to join our team in Schwabenheim, near Mainz in fulltime and permanent contract.

**Requirements**:

- Provide QA support for the GLP systems in the test facility to ensure the maintenance of compliance of the GLP Quality Program
- Function as a resource to resolve GLP or regulated lab area issues and participate in the development/enhancement of QA procedures, guidance documents and audit tools to ensure global GLP QA consistency.
- Provide support for planning, scheduling, and performing compliance training.
- Maintain documentation of QA tasks in compliance with associated requirements and internal SOPs.
- Lead or support activities for authority inspections.
- Provide support for global QA initiatives and keep current on QA trends.
- Communicate across R&D QA team and foster a productive and efficient team environment.

**Qualifications**:

- Bachelor’s or higher degree in an appropriate science or equivalent field (e.g., biology, chemistry, etc.).
- At least 3-5 years of relevant experience in a regulated pharmaceutical Quality Assurance role,
- knowledgeable in computer system validation and equipment qualification requirements of OECD GLP
- experience with electronic document management systems (e.g. Documentum, Veeva, ETQ)
- high level of professionalism,
- demonstrated oral and written communication skills,
- demonstrated understanding of related fields (e.g. analytical methods, statistics, drug development lifecycle)
- leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details)
- Knowledge of first-in-human studies desired
- Verbal and written proficieny in German and English

**Our Benefits**:

- Trustbased working hours (37.5 hours/week) and an attractive company pension scheme
- Competitive salary package: 13 monthly salaries + holiday pay (EUR 1,200 annually) + target bonus achievement
- 30 days holiday entitlement
- Hybrid working model
- Internal further training and promotion opportunities
- International cooperation
- On-the-job training
- Contribution of own ideas to the process design
- Insights into the development of veterinary medicinal products
- Corporate benefits and free (e-) parking spaces
- Good company canteen and a company health management system

Our Animal Health Research & Development team work tirelessly to invent solutions to improve the health and wellbeing of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements**:
25%

**Flexible Work Arrangements**:
Not Specified

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
siehe JD
**Requisition ID**:R247455