JOB POSITION SUMMARY
Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.
DUTIES & RESPONSIBILITIES
Develops standard operating procedures, specifications, and provides technical transfer and validation support.
Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation.
Audits and approves quality, engineering and validation documents for conformance to business practices and departmental procedures.
Provides data and documentation in support of the development of validation strategies.
Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products.
Provides sampling plans and approves inspection methods for evaluation and testing of components and products.
* Support R&D function to ensure quality assurance within product and process development projects by:
* Performing risk analyses
* Drawing up the risk management plan and report
* Drawing up validation plans and reports
* Auditing the Design History File
* Participate during Design Reviews
* Support Quality System:
* Maintain the quality system
* Franchise procedures and regulatory standards roll-out,
* Compile and report metrics
* Provide input to the Site Management Review
* (Co-)supervising external (including DEKRA/FDA) and internal audits (CQA)
* Support Quality Operations by:
* Addressing non-conformities within production and taking care of internal escalations
* Guiding planned deviations from the production process
* Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures
* Analyzing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process
EXPERIENCE & EDUCATION
Education: University/Bachelor’s Degree or Equivalent
Work Experience: 6-8 years of relevant work experience, preferably in the pharmaceutical or medical-device industry
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS
Specific knowledge
- Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971
- Knowledge of quality assurance systems (QMS)
- Knowledge of relevant work rules and procedures
- Knowledge of MS Office
- Knowledge of validation of technical systems and processes
- Knowledge of statistics and quality improvement techniques
Attitude/ Skills
- Communicative
- Flexible and accurate
- Able to function both independently and in a team
- Excellent command of Dutch and English language