QA Master Data

5 dagen geleden

Breda, Noord-Brabant, Nederland Talentmark Voltijd

We are looking for a detail-oriented colleague, with strong communication skills and the ability to work under pressure.

Expectations / Scope / Complexity

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:

Works under general direction.

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.

Minimum Requirements:

  • 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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