For our client, a Biopharmaceutical company in Hoofddorp, we are looking for a QC System Specialist.
In this role, you will lead the QC System life cycle, whose primary goal is to support the QC department and data management while ensuring cGMP compliance. The QC System Specialist will be responsible for the management of all resources (QC system, data management & security, System alarms, documentation among others) to ensure timely delivery of high-quality support to the QC department.
- Management of the whole life cycle of all QC systems
- Ensure calibration and Maintencence is excecuted in a timely manner without impacting the release testing and instrument availability on the lab, acting as the main point of contact for the maintenance team to minimize equipment downtime.
- Act as an advisor and technical resource to quality control department
- Coordinate and perform training of new personnel
- Coordinate and work with the team to troubleshoot issues and provide solutions to minimize equipment downtime.
- Organize and prioritize daily tasks to ensure an efficient process and timely review and release.
- Monitor the GMP systems currently in place to ensure compliance with documented policies and safety regulations
- Lead investigations and supporting continuous improvement initiatives
- Write, review and/or implement deviations, change controls and CAPAs
- Write, review and/or implement changes to controlled documents (SOPs, Specifications, Methods, etc.)
- Write, review and/or implement changes to validation documents (VMP, URS, risk assesments, IOPQ, data flow)
- Support the data management team by conducing vulnerabilities assesment and improvements on QC systems (software)
- User management of QC systems and review of this according to procedures.
- Perform audit trail and parameters review of QC systems.
- Act as a SME during audits and Regulatory Inspections
- Interact with other departments and within QC in a professional manner and join in applicable meetings
- Support other groups within QC to reach the departmental goals
- Perform other duties as required by QC management
- Good working knowledge of GMPs, regulatory requirements
- Proficient in the application of QC principles, concepts, industry best practices and standards
- Experience with qualification and administration of QC equipment (including 21CFRpart11 compliance)
- Management, organization and prioritization skills
- Strong interpersonal skills and willingness for teamwork
- Previous hands-on experience in QC systems (Like QC instruments including software and LIMS)
- Experience at performing and concluding investigations
- Experience in writing and implementing deviations, change controls and CAPAs, writing or updating SOPs, reports and risk assessments
- Strong verbal and technical writing skills (English)
- Experience with participating in audits (regulatory, customers, inter-organizational)
What do we offer
- 12 month contract via Kelly Services
- Start date: ASAP
- An international environment where you can learn a lot in challenging project
- Joining a team in which people of all backgrounds and experiences are respected, and where working together while being focused on saving lives by finding the cure for cancer is a daily activity.
T: +31 658811958
When interested please react through the application process with your English resume.
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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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.