Quality Systems Specialist
Company: International Biopharmaceutical organization
Location: Amsterdam Area
Start: December 2021
As the QC System Specialist for the QC Service group you will be 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.
The QC Service group is part of the Quality Control department. The Quality Control department ensures consistent quality throughout the manufacturing process by providing accurate testing of Incoming Goods, in-process samples, final product, environmental monitoring, and stability samples. The team is diverse, enthusiastic and hard-working.
You will be reporting to the Team Lead of QC Service.
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.
You will be involved in improvement projects of the lab and designing the processes that will make the QC laboratory more efficient and compliant as well as participate in building a team of qualified individuals. Due to the nature of the product and speed of treatment, this role requires a high level of proficiency and ownership of the process.
Your responsibilities, among others, will be:
• 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.
• Ensuring instrument availability on the lab, including new equipment introduction and acting as 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
Challenges of the Role
• Working in a fast-paced environment: coordination of a large number of items with tight timelines
• Maintain compliance and safe working environment despite time pressure
• Take part in developing the QC department, documentation, processes and culture
The ideal candidate has a can-do attitude and thrives in a fast-paced environment. Because the QC group is involved daily with multiple departments, a strong ability to communicate and coordinate is essential to ensure a smooth and efficient process. The ideal candidate should possess a technical mind but is also able to think outside the box in order to use logic and sound judgment to provide solutions to problems.
• A BSc degree and 4-6 years of experience in the Biotech and/or Pharmaceutical Industry
• 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)
• Project management skills
• Experience at performing and concluding investigations
• Experience in writing and implementing deviations, change controls and CAPAs
• Experience in writing or updating SOPs, reports and risk assessments
• Strong verbal and technical writing skills (English)
• Experience with participating in audits (regulatory, customers, inter-organizational)
• Willingness and ability to join corporate meetings in the (early) evening, when required.
• Comfortable in a fast-paced environment with minimal direction
• Ability to set and adjust priorities, and separate the essentials from the details
• Flexible, strong organization skills, and a strong team player
• Excellent English communication skills
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’ t miss out on this opportunity and apply this position.
Questions or Remarks?
If you have additional questions or remarks concerning this vacancy please do not hesitate to contact me.
Stijn van der Kleij
+31 20 65 898 00