Do you have a shop-floor experience as a QA employee in pharmaceutical supply chain (preferably a former GDP Responsible Person at a logistic service provider)? Do you have at least 5 years' experience in GDP? Fluent in NL and ENG? And also ready to work in Nijmegen (The Netherlands)? Then we've got the job for you!
Our client is currently looking to recruit a contractor for to provide support in the implementation of a project in Nijmegen (The Netherlands). We are looking for a skilled & competent QA contractor addressing the requirements in the below job description.
It is crucial that this person has shop-floor experience as a QA employee in pharmaceutical supply chain (preferably a former GDP Responsible Person at a logistic service provider).
Key objectives of this position include:
- Quality Management & Process development:
- Ensure GMP & GDP critical documentation generated during assigned projects is properly prepared, managed and archived
- Quality Systems:
- Support in the Design and deployment of compliant, robust, aligned, lean and efficient quality systems and tools at the LSP to support GMS and commercial strategy, and to support the product lifecycle and supply flow,
- Technical & Validation:
- Ensure Technical transfer, Scale-up & Installation of new processes & new operations onto and with-in at the Logistical Service Provider.
- Risk management
- Designing and implementing a quality risk management process to help monitor and control systems and to identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle and supply flow
- Lead and oversee site training plan,
- Oversee Site License registration process
- Quality Culture
- Serving as a quality culture role model and instil a strong quality and compliance culture across the site.
- Operational Excellence:
- Assure the use of operational excellence's tools in quality procedures and processes,
- Monitoring & Escalation
- Immediate notification to the SCL QO Quality Leader any quality issues, and provide accurate and relevant information as required by the business
- Represent the Quality PMO in cross-functional project meetings
- Relevant advanced degree (Pharmaceutical or Biomedical Sciences or any other relevant scientific Masters degree)
- Strong leadership, communication, decision making and problem solving skills
- 10 years relevant experience in Pharmaceutical and/or Animal Health industry
- Demonstrated success in project management
- Preferably experience with operational excellence tools
- Experience of working in a cross functional team in a highly regulated environment
- Experience with cold-chain storage activities
- Success in developing, implementing and maintaining Quality Systems and Standards within pharmaceutical logistics or manufacturing sites
- Experience with site commissioning activities & validation of premises and computerized systems
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
- Strong written and oral communication skills
- Drives for Superior Results and Passion to Win
- Inspires Continuous Improvement and Breakthrough Thinking
- Proficient in Dutch and English
- Ability to travel on a frequent basis (Benelux)
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17621