Quality Specialist Operations
We are looking for an enthusiastic and motivated colleague who is excited to help us to strengthen our Operations Team, somebody who would like to contribute to a high-quality organization.
You will be the primary point of contact for Operations regarding cGMP-related activities such as the deviation and change control process, audits, evaluations, trend reports, cGMP compliance and training within Operations with that responsibility for the improvement of the overall quality status. You will work and have the drive for deviation and change control process and represents Operations.
You must build a strong network within the company; be involved in GMP-related projects and adjustments. The activities are very dynamic and varied. The candidate loves challenges, doesn’t avoid problems, and enjoys working in various teams. You need a high-level overview and have a GMP-mind to support all ongoing investigations.
- Ensure that in a timely manner clear and quality input is given to cGMP and/or quality-related issues encountered during (non)routine Operations. Lead all aspects of quality record investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
- Raise serious quality, compliance, and /or GMP incidents to Operations Management.
- Setup and coordinate Site critical issue meetings.
- Identify improvements within Operations in Quality records and implement these in the process and/or documentation.
- You will own the deviations within Operations. This implies
- establishing and maintaining a structured deviation process
- representing Operations in improvement projects
- You are responsible for drawing up and finalizing change controls
- BSc in science-related subject and /or business-related area with 6 years of experience
- Msc in science-related subject and/or business-related area with 4 years of experience
- Experience with software TrackWise
- Quality (Pharm) and GMP background
- The ability to work in a complex environment, keeping a high-level overview of records.
- Leiden, Netherlands