QA Systems Specialist - CMMS

QA Systems Specialist – CMMS

Location: Hillerød, Zealand Region

Category: Quality and Compliance

Salary: Apply for details

Country: Denmark

Employment: Contract

Worksite: On-Site

An experienced QA Specialist is required to support QA oversight activities across Quality Control and Drug Substance manufacturing. This is a hands on role focused on quality review and approval of maintenance and calibration records within a regulated biotech environment.

The role

You will support QA teams by reviewing and approving CMMS work orders linked to maintenance and calibration activities. The position sits at the interface of Quality Control and manufacturing, ensuring compliance with GMP standards and data integrity principles.

Key responsibilities include

• Review and approve CMMS work orders for maintenance and calibration activities
• Ensure alignment with GMP, data integrity and internal quality standards
• Support deviation handling including investigation and root cause analysis
• Work closely with QC, manufacturing and engineering teams
• Provide clear feedback to stakeholders and challenge where required
• Ensure timely completion of quality activities to meet deadlines

Experience Required

• 5 years QA experience in a GMP regulated pharmaceutical or biotech environment
• Strong experience with deviations including investigation and approval
• Hands on experience with CMMS systems
• Familiarity with eQMS and ERP platforms such as Veeva, TrackWise or SAP
• Solid knowledge of GMP and data integrity principles including ALCOA+
• Strong technical writing and documentation skills

Education

• Degree in a life sciences discipline

Profile

• Detail oriented with a high level of accuracy
• Self driven and proactive
• Able to manage deadlines in a fast paced environment
• Strong communicator across functions and stakeholders

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.