We are looking for a senior validation specialist with experience in the pharmaceutical industry. You are responsible for (c)GMP compliance, technical reports and other sources of information to ensure that validations and procedures are consistent with the industry wide standards. You will also be representing the Quality Assurance department in projects teams and are the go to contact for validation issues.. If you are a subject matter expert in the field of validations, apply now.
As a validation specialist you are the backbone of the team, ensuring that all documentation is following the correct GMP guidelines and that the quality is adhering to industry standards.
- Reviewing and approving technical reports to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology.
- Ensure that validation, qualification and other life cycle activities are consistent with company validation policies and procedures and federal regulations.
- Proceed according to the company's quality policy in all business activities with providers and customers within and outside the company.
- Evaluate technical problems and provide recommendations for corrective actions.
- Represent Quality Assurance department in project teams.
- Participate in company meetings related to changes in processes, process improvements, provide suggestions, and so on.
- Provide coaching and training and guidance on aspects of validations and qualifications.
- Provide support to internal and external customers of site quality in the execution of procedure and policy requirements.
- Act as a major contact for validation issues during regulatory and third party audits.
- BSc or MSc in bioscience, pharmacy or biochemistry. (PhD is overqualified).
- 8-10 years of relevant working experience in Quality Assurance
- Knowledge of bioassays.
- Proven excellent knowledge on GMP-guidelines.
- Good technical writing skills in English.
- Knowledge of statistical data analysis.
- Excellent communication and decision-making skills.
- You have a valid working permit for the Netherlands.
Terms of employment
- One-year temporary project, contract trough Oxford Global Resources.
- Salary indication: from €4000 to €5500 gross per month
- Working hours: fulltime; 40 hours per week.
- Location: Leiden region
Vacancy number: 16135