Our client, who is an international pharmaceutical, is looking for Pharmaceutical Specialist (Quality Specialist - QA and technical) (fluent Dutch AND English must, 40 hours) in Amsterdam area.
All applicants MUST have full legal authorization to work in the EU region independently and be fluent in both spoken and written English language.
Do you have at least 5 years'of experience in a GMP environment? Do you have work experience in QA AND technical department such as Facility, Maintenance or Engineering? Do you have broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions? If yes, read further!
As Quality Specialist, you'll be joining a newly formed team, in which employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You'll be reporting to the Senior Manager Maintenance & Calibration
You'll be part of the Facility & Engineering team for the new manufacturing site. In this role you will be part of the technical team, responsible for supporting deviations, CAPAs, change control and front line support for our client's commercial manufacturing site producing autologous T-cell therapy products.
- Provide front line technical support for the Technical supporting departments
- Ensure successful Facility & Engineering operational activities by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and calibration issues
- In conjunction with various internal and external stakeholders, investigates writes and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools and product impact assessments.
- Issues and implements CAPAs to address root cause and ensure effectiveness
- Collaborating with technical and operational stakeholders, writes and/or revises SOPs, and other operational related documents
- Trends key performance metrics
- Participate & represent F&E department during audits/inspections
- Represents Facility & Engineering operations in Change Control, CAPA and Deviation meetings
- Conducts Compliance related training and cGMP guidance to the technical Staff
- Other tasks and duties as assigned by Management
- BSc in a Technical field
- Minimum 5 years of experience in a GMP environment
- Fluent in Dutch and English
- Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
- Knowledge of Technical installations, equipment and maintenance
- Proficiency in Quality systems
- Utilizes technical writing strategies to ensure content is clear and concise
- Work experience in technical department such as Facility, Maintenance or Engineering
- Preferably experience as Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar
- Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities
- Possesses good communication skills
- Ability to function efficiently and independently in a changing environment
What do we offer
- Contract via Kelly Services
- Start date: ASAP
- Contract: 6 months, 40 hours
- Working days: Monday-Friday, 8:30-17:30
- Salary indication depending on experience
Please do contact Marcella Henryati, Recruitment Consultant
When interested please apply with your English resume on our website: www.kellyservices.nl
About Kelly Services
It's more than a job. It's passion. Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.
At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.
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