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Senior Specialist Quality Assurance Systems

vor 3 Monaten

Krems an der Donau, Niederösterreich, Österreich Merck Sharp & Dohme Corp. Vollzeit

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.

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 new production facility in Krems a.d. Donau we are looking for an experienced

Senior Specialist Quality Assurance Systems (m/f/d)

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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Project Temps (Fixed Term)

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/5/2024

*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.

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.

Requisition ID:R306896