MSD Senior Specialist Quality Assurance Systems m/f/d 

Austria, Lower Austria 

567684552

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.

For our new production facility in

Fixed-term for 2 years

(Full-time, as soon as possible)

The Specialist Quality Assurance Systems will provide Quality support in preparation of a USDA certification and further support the site for product transfer projects according to Austrian Drug Law (AMG), European GMP, EU 2019/6 and USDA at Krems Site, Austria.

Key attributes of the position:

• Responsibility for one's own safety and that of the immediate environment.

• Perform compliance gap assessments vs USDA requirements

• Coordinate remediation action implementation ensuring timely completion.

• Perform quality remediation actions such as creation, review and approval of relevant SOPs, qualification and validation protocols and reports, manufacturing instructions, GMP documents included but not limited to warehouse, manufacturing, QC, maintenance, engineering

• Participate and support official inspections and self-inspections

• 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 locally and globally to foster strong relationships with management and colleagues to drive a safe and compliant culture.

Qualification and Experience:

• Minimum a bachelor’s degree in (Bio)chemistry, Biology, or scientific field

• Minimum 7-8 years of experience in a Pharmaceutical GMP environment

• Knowledge of USDA requirements for US animal health vaccines is of advantage

• Good knowledge of EU GMP regulations as well as (V)ICH (Veterinary International Conference on Harmonization) guidelines

• Knowledge of PDA, ISPE (International Society for Pharmaceutical Engineering) guidances

• Good project management skills

• Fluent in German and English

• Autonomy in working through one´s own responsibilities and make decisions for necessary remediation actions.

We offer:

• Unique possibility to participate in the establishment of a state-of-the-art production site

• Diversified responsibilities in an international surrounding

• Collaboration with professional and highly motivated team members

• Participation in a respectful and positive working climate

• Attractive career opportunities as well as good training and development possibilities

• Attractive company benefits

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 59.200,- and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Current Contingent Workers apply

Project Temps (Fixed Term)

Not Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:10/05/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.