Quality Management Records Owner

3 weken geleden

Breda, Noord-Brabant, Nederland Real Staffing Voltijd

Job Vacancy: Quality Management Records Owner (Change Controls, Deviations, CAPAs) Location: Breda

Role Overview: As the owner of engineering change control, deviation, and CAPA records, you will ensure the completeness, accuracy, and effectiveness of these records. You will maintain all quality records in compliance with relevant regulations and company quality standards, ensuring timely completion.

Key Responsibilities:

  • Change Controls:
  • Manage the change control process.
  • Ensure all changes are documented, reviewed, and approved according to regulations and company standards.
  • Deviations:
  • Document deviations.
  • Lead Root Cause Analysis meetings to identify root causes.
  • Implement corrective/preventive actions.
  • CAPAs:
  • Ensure corrective and preventive actions to address identified issues and prevent recurrence are documented and tracked to completion.
  • Collaboration:
  • Work closely with various cross-functional teams to ensure the accuracy and completeness of quality records.

Qualifications:

  • Education:
  • Bachelor's degree in a related field (e.g., Engineering, Life Sciences).
  • Skills:
  • Excellent technical writing skills.
  • Strong analytical and problem-solving skills.
  • Excellent communication and organizational skills.
  • Experience:
  • Minimum of 3 years managing Change Controls, Deviations, and CAPAs in a GMP-regulated environment.
  • Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA) and Root Cause Analysis (RCA).
  • Experience interacting with regulatory agencies (preferred).
  • Knowledge:
  • Strong knowledge of regulatory requirements like Eudralex Annex 15, FDA CFR 21 Part 210 and 211, and best practices in quality records management.
  • Language:
  • Fluent in English.
  • Work Style:
  • Ability to work independently and collaboratively.

Contract Info:

  • Initial 1-year contract with the aim for long-term employment.

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