Senior Quality Specialist

vor 3 Wochen

Krems an der Donau, Österreich MSD Vollzeit

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.

For our site in **Krems**, we are currently looking for a:
**Senior Quality Specialist** (M/F/d)**

The Senior Quality Specialist provides Quality support and oversight according to Austrian Drug Law (AMG), European GMP, EU 2019/6 and USDA at Krems Site in Austria.

**Main tasks**
- Responsibility for one's own safety and that of the immediate environment
- Participate and provide QA leadership for investigations and risk assessments related to deviations, complaints and changes, ensuring appropriate actions are implemented timely
- Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements
- Review and approve relevant SOPs, qualification and validation protocols and reports, manufacturing instructions, GMP documents included but not limited to warehouse, manufacturing, QC, maintenance, engineering
- Provide guidance on GMP and ensure quality and compliance with the relevant GMP regulations, such as EU GMP guidelines and pharmacopoeias
- Participate in and support risk management activities in line with relevant guidance and best industry practice
- Participate and support official inspections and self-inspections
- Participate in projects for quality improvement, transfer and optimization of products and methods
- Contribute to the implementation of quality and compliance excellence for continuous improvement and increase in efficiency throughout quality and, where necessary, support initiatives at the site and company levels
- Work collaboratively to foster strong relationships with management and colleagues to drive a safe and compliant culture

**Skills**
- Minimum a bachelor’s degree in microbiology preferred, (Bio)chemistry, Biology, or scientific field
- Minimum 10 years of experience in a Pharmaceutical GMP environment
- Good knowledge of EU GMP regulations as well as (V)ICH guidelines
- Knowledge of PDA, ISPE guidance
- Experience in aseptic processes
- Eligible to be a Qualified Person preferred
- Fluent in German and English

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.

**Secondary** Language(s) Job Description**:

- Minimum a bachelor’s degree in microbiology preferred, (Bio)chemistry, Biology, or scientific field
- Minimum 10 years of experience in a Pharmaceutical GMP environment
- Good knowledge of EU GMP regulations as well as (V)ICH guidelines
- Knowledge of PDA, ISPE guidance,
- Experience in aseptic processes,
- Eligible to be a Qualified Person preferred
- Fluent in German and English

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
Domestic/International

**VISA Sponsorship**:
No

**Travel Requirements**:
10%

**Flexible Work Arrangements**:
Hybrid

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
Yes

**Job Posting End Date**:
07/12/2024

**Job Posting End Date**:07/12/2024

**Requisition ID**:R292809

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