Associate Specialist Quality Assurance Systems

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

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.

For our site in Krems, we are currently looking for an:
**Associate Specialist Quality Assurance Systems (M/F/d)**
- (Fixed term for 2 years, Full-time)_

The Associate Specialist Quality Assurance Systems will be responsible for the quality aspects of key Quality systems with a focus but not limited to GMP computerized systems and supporting infrastructure to ensure compliance with company policies, procedures and regulatory expectations.

The Associate Specialist must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

**Main Responsibilities**:

- Support/drive maintenance and improvement of established Quality Systems
- Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and Company IT Owner)
- Providing the independent quality approval of key qualification and validation documentation to ensure compliance to company standards and applicable regulations
- Providing the independent quality review and approval of changes / deviations / compliance investigations, CAPA.
- Supporting regulatory inspection and audit activities.
- Driving resolution of regulatory non-conformance.
- Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
- Promoting GMP awareness and a culture of continuous improvement and supporting manufacturing process improvements, laboratory operational excellence and validation activities.

**Requirements**:

- Bachelor's degree or other equivalent education, preferably in Engineering, Biotechnology or relevant experience
- Experience in a regulated pharmaceutical manufacturing and/or laboratory environment, Quality or Compliance role in GMP environment desired (FDA/EU/ICH)
- Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory or biotechnology manufacturing environment
- Operate as part of a self-directed team in carrying out day to day functions and assigning priorities
- Excellent oral and written communication skills including developing cross functional relationships
- Analytical problem-solving skills to issue identification and resolution
- Fluency in written and spoken German and English

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 44.100;

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
Domestic

**VISA Sponsorship**:
No

**Travel Requirements**:
No Travel Required

**Flexible Work Arrangements**:
Hybrid

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
N/A
**Requisition ID**:R287636