Senior Quality Specialist

vor 2 Wochen

Krems An Der Donau, Österreich MSD Vollzeit

Job Description

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 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:

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:

07/11/2024

*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:07/11/2024


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:R292809

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