Functiebeschrijving
- -
Quality Assurance Content Manager
Job Title: Quality Assurance Content Manager
Job Family : Content Manager (seniority: Medior)
Location: Woerden, the Netherlands
Reports to: Head of Quality Assurance
The Role
As a Quality Assurance Content Manager (Medior Level) , you will report directly to the Head of Quality Assurance. In this role, you will be responsible for managing and maintaining quality records and processes within our DMS/QMS systems, while supporting and safeguarding a broad range of quality assurance activities.
Your responsibilities will include maintaining and improving quality systems related to GDP compliance, client project management, vendor and product qualification, quality control, data and computerized system governance, continuous improvement initiatives, and monitoring regulatory and standard updates.
i+solutions is a GDP, MQAS and ISO 9001:2015 certified organization and ISO 27001-ready company, committed to delivering healthcare products worldwide based on unmet medical needs.
As Quality Assurance Content Manager, you will contribute directly to improving access to medicines by helping ensure the continuous supply of safe, high-quality healthcare products to people who need them most.
Qualifications
- Bachelor's or Master's degree in Pharmacy, Life Science or other relevant field or equivalent experience. - 8+ years background in a QA role within Life Science environment, with QA and QC experience - 8+ years of experience with GDP, preferable MQAS and GMP standards - Qualified lead auditor in ISO and GxP norms - Experience in inspectorate preparation and management activities - Thorough knowledge of ISO standards 9001, and preferably knowledge of 14644 and 17137, ISO 13485, ISO-27001 and ISO 31000 experience is an advantage - Eligible to work as an RP and/or QP in the Netherlands and EU - Experienced in maintaining quality records and QMS /DMS -rel...