We are looking for a detail‑oriented colleague, with strong communication skills and the ability to work under pressure.
Objectives
- To perform QA review and approval for SAP Master Data and artwork.
- To ensure QA systems are maintained, improved and performance is appropriately monitored.
- To establish effective working relationships with the Global Artwork Center, Master Data, SCPM, Site SMEs and RA department, as well as QA Management.
Position Specific Tasks
- Perform review and approval of Master Data related activities (such as critical value verification and Bill of Materials).
- Perform approval of artwork for medicinal products.
- Act as author for operational SOPs and Work Instructions.
- Perform QA review of operational SOPs and Work Instructions.
- Participate in QA-related projects as needed.
- Assist in investigations and deviations as required.
Problem Solving
Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
- Ensures compliance within a regulated environment.
- Develops solutions to technical problems of moderate complexity.
- Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues.
- Interprets generally defined practices, procedures and methods.
Autonomy
Work is guided by departmental objectives or specific assignments.
- Refers to technical standards, principles, theories and precedents as needed.
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognizes issues and escalates appropriately.
Contribution
- Contributes to the work group/team by ensuring the quality of tasks and services delivered.
- Supports the completion of milestones associated with specific projects or activities within the department.
- Provides training or guidance to others and acts as a technical or scientific resource within the team.
- Establishes effective working relationships with stakeholders outside own area of expertise.
- Requires MBO or Bachelor’s degree in Life Sciences or a related field, or an equivalent combination of education and experience. This position is also suitable as an entry‑level role for candidates with a Master’s degree in Life Sciences.
- Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry; however, people with limited but relevant experience are also encouraged to apply.
- Basic knowledge of Good Manufacturing Practice (GMP). Knowledge of GDP and/or GCP is considered a plus, with the ability to interpret and apply guidelines in mainly routine cases.
- Fluent in English (spoken and written).
- Accurate and detail‑oriented mindset.
Additional Role Information
- Contract duration: 10 months (maternity cover).
- Start date: Preferably end of January or first week of February, not later.
- Availability: you must be available for interviews from the first week of January.
- Work model: Hybrid role, with a minimum of 2 days per week on site.
- Extension possibility: Currently uncertain.
- Urgency: This is a time‑critical role; early joiners are strongly preferred.
- Hiring timeline: CV screening will start immediately, with the intention to close the role by mid‑January.
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Breda, North Brabant, Netherlands
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