Excellent opportunity for an experienced Projectleader Quality Assurance within a a dynamic, international and fast-paced work environment.
Over de functie
Are you an experienced Project Leader with knowledge in a wide range of laboratory techniques & scientific communication and good laboratory practices? Do you like leading a wide variety of projects and taking responsibility into your own hands? Do you enjoy working in dynamic cross functional teams? Do you have excellent project and time management skills, as well as an ability to communicate, negotiate and influence? If the answer to these questions is yes, then we would like to hear from you.
The scope of the position is to ensure:
- the technology and knowledge transfer from affiliates in term of product and process quality for new products;
- quality manual is implemented;
- SOP's related are appropriately validated while conducting review of related documentation and leading quality risk assessment and change management activities.
- Audit Management
- Management Review
- Product & Process Review
- Product & Process Non-conformity Management
- Quality Data & Trend Analysis
- Batch Release Management (incl. Batch Records Review)
- Sampling plan Management
- Customer Complaints
- Corrective & Preventive Actions
- Define and establish validation strategy, plans and related procedures to provide guidance to project and process engineers to qualify and validate manufacturing process, equipment and utilities.
- Define and coordinate quality risk assessment approach and ensure mitigation plans are defined, followed up and resolved by subject matter experts.
- Manages relationships externally and internally.
- Builds cross-functional and cross-departmental support, fostering overall effectiveness. Ensure compliance through assisting in audits. Ensure that all validation activities are carried out and reported in a timely manner.
- Provide high level qualification and validation expertise and support to many different partners that have different level of understanding and practices.
- Lead implementation of master batch record, in collaboration with impacted Quality Assurance departments and establish the flow to ensure proper batch release process. Establish proper archiving of master batch record and batch release documentation. Sign and approve master batch record as Quality Reviewer and batch release in case of head of Quality Assurance unavailability.
- Organize and manage the work of team members, motivate them and encourage professional and career development so as to enable them to perform all the assignments. Ensure skill matrix availability for each role and define a training path and plan for each team member.
- Master degree in Chemical Engineering, Chemical / Biological sciences or Physical sciences;
- At least 5 years experience in Quality Assurance in pharmaceutical, food or similar industry;
- Experience in leading implementation/validation of new products;
- Advanced knowledge of relevant standards (ISO, ICH, GMP and GLP);
- Experience in environment working with FDA certifications is an advantage;
- Fluent level of written and spoken Dutch and English;
- Availability to travel abroad.
You will join a dynamic, international and fast-paced work environment in a constantly evolving industry and will interact with different levels of experience and expertise across the company. Our client offers a permanent contract with competitive salary commensurate to the professional experience.
Above all, our client offers you a fresh perspective. Here, you will never stop exploring and discovering. They take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. This position will advance your experience with innovative technologies, services, and processes. Backed by a competitive salary and compensation package, you will work in a professional setting with clients and team members from all over the world.
Our client is a worldwide leader in their field of products. The factory in Bergen op Zoom employs approximately 200 employees. Here the semi-finished products are produced and they provide logistic services for other factories. An impressive place to work.
Voor meer informatie neem je contact op met Esther Riesenbeck via telefoonnummer 06-23001761
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.