QC System Specialist

01 October 2021
SalaryNegotiable
LocationHoofddorp
Temporary
DisciplineLife Science Careers, Quality Assurance/Safety
ReferenceBBBH484612_1633086067

For our client, a Biopharmaceutical company in Hoofddorp, we are looking for a QC System Specialist.

Role

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.

Responsibilities

  • 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


Requirements

  • 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.


Marcella Henryati
T: +31 658811958
When interested please react through the application process with your English resume.

About Kelly Services
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