Job Description

We are seeking an experienced QA Specialist - R&D (m/f/d) to support our R&D QA department in ensuring compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. The successful candidate will review validation documents, perform audits, and provide guidance on compliance of computerized systems as well as on preclinical and clinical studies in a regulated environment.

Key responsibilities:

Serve as the primary QA contact for local R&D functions and IT regarding the implementation and validation of digital solutions and computerised systems.

Support digitalization by reviewing qualification and validation documents.

Provide expert guidance on policies and regulatory requirements in project teams.

Collaborate and communicate with stakeholders and global team members.

Conduct and manage audits for compliance with GLP and GCP regulations, specifically for clinical and preclinical studies.

Support during regulatory inspections and conduct supplier audits as required.

Develop and conduct training on compliance-related topics.

Qualifications & competences:

Bachelor’s or Master’s degree in Life Sciences, Information Technology, or a related field.

Minimum 3 years of experience in regulated GxP environment and QA auditing.

High affinity for digital solutions and technical knowledge of industry IT topics. Understanding of computerized systems validation and SDLC is a pro.

Mindset that demonstrates the confidence, resourcefulness and proactive acting.

Demonstrated ability to work as both a team player and independently.

Innovative problem-solving, critical thinking, compliance knowledge and high affinity for documentation requirements in regulated industry.

Benefits:

Flexible working hours (37.5 hours/week) and an attractive company pension scheme

Competitive salary package: 13 monthly salaries + holiday pay + target bonus

30 days holiday entitlement

Hybrid working model (up to 50 % remote)

Internal training and promotion opportunities

International co-operations

Training on the job

Contributing your own ideas to the process design

Insights into the development of veterinary medicinal products

Corporate benefits and free (electric) car parking

Good company canteen and a company health management program

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:

No relocation

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:

12/21/2024

*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:R324857