Quality by Design, in short QbD is a knowledge organization and quality partner for companies in life sciences. We support in the development of qualitative and advanced therapies and technologies for the benefit of patients and consumers worldwide.
Do you have extensive QA and/or Validation experience in an industrial environment? Then this position as Validation Specialist might be for you!
Validation Specialist, Netherlands & Belgium
As a Validation Specialist you work on multiple projects in the Netherlands within several organizations within the pharmaceutical, ATMP’s or Medical device related industry. You are responsible for effective and efficient validation and qualification of computerized systems, laboratory equipment, cleanrooms, utilities, HVAC systems, GMP production equipment, medical devices and processes.
- Provide Quality and validation oversight to ensure that validation, qualification and other life cycle activities are consistent with company validation policies, procedures and federal regulations;
- Support process validations (IQ/OQ/PQ) and test method validation;
- Identify critical areas for improvement and prioritize and execute the initiatives. Perform or support nonconformance / CAPA root cause investigations, defining action plans and driving these to completion;
- Proceed according to the company's quality policy in all business activities;
- Provide advice to improve the quality policies and validation procedures
- Represents Quality Assurance department in project teams;
- Provide coaching, training and guidance on validations, quality and CSV;
- Ensure change control procedures are followed to maintain the system including its software in a validated state throughout the life cycle;
- Manage and execute periodic reviews;
- Implement controls to ensure data integrity and traceability of Quality records;
- Act as a subject matter expert during internal and external audits (e.g. FDA).
Who we're looking for
- BSc or MSc degree in Life Science & Technology, Exact Science, Computer Science or Engineering;
- Experience in QA, computer system validation (CSV) or in automated processes and working knowledge of validation of products/equipment/processes/risk management/data integrity;
- Knowledge of GMP, FDA, EMA and local guidelines
- Pro-active, result driven, flexible, detail oriented, and able to function independently as well as in a team.
QbD is a healthy company with a strong growth and international ambitions. QbD offers worldwide expertise and solutions in the field of Quality Management, Validation, Project Management and Regulatory Affairs for companies active in the life sciences, healthcare and cosmetics industries. Our footprint JPEG: Joy, Partnership, Going the Extra Mile and Getting things done.