We are recruiting for a Quality Compliance Officer on behalf of our Multinational Pharmaceutical Client on an initial 4 month contract based in the Haarlem area, Netherlands.
Monitoring and maintaining the quality (compliance) of bulk products, finished products and packaged products such that the EU GMP, the registration dossier, the national legislation (commodities law) and the guidelines are met.
Essential Duties & Responsibilities Please list the duties from high to lower workload in%
1 Quality System deployment: supporting the Qualified Person in (inter) national asked stringent standards and corporate rules.
- Create and keep up to date by standard operating procedures and work instructions according to the company standard and in accordance with the national rules
- Perform GMP and GDP compliance on commercial quality Department and promoting the quality culture
- Initiating and executing improvement processes (continuous improvement)
- Monthly the relevant KPI data of the Department available to reports (both internal and external)
- Timely follow-up and finishing deviations, changes and CAPA's.
Operational implementation Quality Management System (QMS):
Supervising (subject matter) the products entrusted (part of the range), both routinely and during deviations or questions with a view to ensuring compliance and quality.
- Formulating risks for quality
- Assessing and supervising the introduction of new products and product changes (Change Control).
- Assessing variations on the influence on registration dossiers, master documents, specifications.
- Formulating risks through the change proposal for the quality of the product
- Formulating validation research, additional tests or monitoring
- Indicate the moment when the change takes effect and formulate the approach during the transition.
- Monitoring of the batches in the transition phase.
- Monitoring the delivery and assessing the results of the authorized investigation, including for validation.
- Preparation of new specifications for batch release.
- Assessing the adjusted production, packaging, test documentation
- Supervising and drafting documentation when placing products with a new contract manufacturer (Site Change)
- Visiting a supplier at home or abroad to assess the status of the GMP level based on the GMP guidelines and internal standards together with the Qualified Person or Associate Director QA
- Participate in audits at contract manufacturers together with the QP or Director QA
- Visit supplier at home or abroad to assess the status of the GMP level on the basis of the GMP guidelines and internal standards together with the Qualified Person or Associate Director QA
- Make proposals to improve quality and efficiency within QA.
- Participate in projects in the field of quality improvement and / or efficiency improvement and / or coordination thereof.
- Experience with handling Deviations and out of specs (OOS) in production processes
- Experience dealing with Deviations and out of specs (OOS) in production processes
- Experience with pharmaceutical production processes
- Experience with pharmaceutical analysis methods
Specialized or Technical Knowledge Licenses, Certifications needed
- Knowledge of pharmaceutical production processes (ampoules, tablets, suppositories, creams)
- Knowledge of European GMP guidelines
- Knowledge of the applicable European Registration Guidelines
- English (speaking and writing)