QA Training and Documentation Specialist

Opdrachtgever

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

Bachelor’s degree in Life Sciences or a related discipline
Minimum 4 years of experience in a GMP environment within biotechnology, biologics, or pharmaceutical manufacturing.
Working knowledge of Quality Systems, including GMP training, document management, and document change control.
Experience with LMS platforms and/or electronic document management systems (e.g., GxPLearn, Document Locator, Documentum, Veeva, or equivalent).
Strong understanding of GMP principles, SOPs, and regulated quality processes.
Proficiency in MS Word, Excel, PowerPoint, Adobe Pro; strong data and reporting skills.
Excellent organizational skills and attention to detail.
Ability to work on multiple assignments with changing priorities.
Strong interpersonal, verbal, and written communication skills.
Ability to work independently and collaborate effectively with technical and scientific personnel.
Sufficient physical fitness to support archival activities, including lifting boxes.

Support the routine operation, configuration, and administration of the Learning Management System (LMS).
Coordinate training logistics, delivery, and administration for GMP, GDocP, and LMS/DMS usage.
Assist with course management activities such as course setup, learner assignments, revision tracking, assessments, and reporting.
Generate standard and ad?hoc training reports and metrics to ensure compliance, oversight, and inspection readiness.
Provide first?line troubleshooting and user support for LMS?related issues and escalate more complex matters when needed.
Maintain the Quality Document Management and Records Management systems, including full document lifecycle activities (archival, retention, and retrieval).
Execute GMP archival activities, including preparation, transfer, secure storage, retrieval, and disposition of quality records in line with retention schedules and regulatory requirements.
Support continuous improvement initiatives within QA Training and Document Control.Collaborate with Quality Systems colleagues on general QS activities as required.