QA Documentation Specialist
- Randstad
- 3000.00 - 4500.00
- 32-40 hours
- Project duration at least a year
- Bachelor degree
Client
Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.
Client
Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world. Their reputation is based on forming successful partnerships with clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
Requirements
- HBO or WO level education in a relevant area.
- 2+ years experience on document management in a regulated environment.
- Experience with documentation review/writing, SOP review/creation, detail oriented, energetic, focused, used to repetitive tasks.
- Advanced level of English communication.
- Ability to prioritize and meet deadlines.
- Demonstrate attention to detail and ability to consistently deliver accurate output in routine accountabilities.
- Advanced technical knowledge of GMP.
- Ability to clearly and concisely present/ explain document issuance operation and its requirements / guidelines.
- Ability to cross train colleagues and customers..
- Ability to communicate effectively with stakeholders.
- Available to work in weekends every 6 weeks.
What do you get?
- Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
- Collective WGA / WIA insurance
- NBBU collective labour agreement through equal remuneration
- 25 holidays days
- 8% holiday allowance
- 100% payment in case of illness in the first year
- Travel allowance per kilometer or through public transport
Duties
- Responsible for the verification of controlled issued batch documents and label packages including Final product labels per cGMP.
- Responsible for verification of controlled issued logbooks.
- Responsible from timely consumption of consumables/GMP materials used or informing the responsible person.
- Ensure accuracy and completeness of QA issued documents.
- Identify and escalate compliance gaps across the controlled issuance process.
- Support/investigate deviations on controlled issuance process and develop effective corrective action plans.
TAGCLOUD
qualityassurance#GMP
#pharma
#specialist
#documentation
#shiftwork
