QC Systems Specialist

Hoofddorp
3000.00 - 4000.00
32-40 uren
Bachelor degree

Opdrachtgever

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

functie Vereisten

Bachelor of Applied Science (BSc) or Master of Science (MSc) degree in Biochemistry, Biology or Molecular Biology or HBO/HLO.
Experience in laboratory techniques
Experience with working under GLP and GMP requirements is preferred.
Able to work independently and in a team.
Able to focus and prioritize between multiple projects.
Strong communication and problem-solving skills.
Ability to work in a multi-disciplinary and international team.
Proficient in English, both speaking and writing.

Wat krijg je?

Pension entitlement as from day one
Collective WGA / WIA insurance
NBBU / ABU collective labor agreement
25 holidays days
8,33% holiday allowance
100% payment in case of illness after one waiting day
Travel allowance

Werkzaamheden

Management of the whole life cycle of all QC systems.
Ensure calibration and maintenance are executed 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.
Keep overview of new systems and ensure implementation timelines are available. Communicate timelines to TL/management in a clear and professional way.
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.
Identify and implement improvements to ensure a Lean process.
Actively represent QC with support from TL in projects regarding QC Systems.
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 assessments, IOPQ, data flow)
Support the data management team by conducing vulnerabilities assessment 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 in a timely manner.
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.