Change Control Specialist

Your challenge

•    Change Control Management:
o    Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to product specifications, manufacturing processes, and controlled documents.
o    Oversee the Change Control Board (CCB) activities, ensuring thorough review and decision-making regarding change risks, impacts, and action plans.
o    Collaborate with cross-functional teams, including Quality, Regulatory, Manufacturing, and R&D, to ensure change controls are well-documented, traceable, and compliant.
•    Product and Process Changes:
o    Assess product and process change proposals to determine compliance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements.
o    Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity.
o    Work closely with operations teams to implement changes and monitor post-implementation to confirm effectiveness and stability.
•    Document Control and eQMS Administration:
o    Manage and Oversee document control processes within the electronic Quality Management System (eQMS), ensuring all controlled documents are current, accessible, and aligned with internal and external standards.
o    Manage document version control and maintain documentation workflows for all changes, including SOPs, technical files, and specifications.
o    Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization.
o    Manage the verification and implementation process of source documents from GBO Centers in cooperation with the departments in charge.
o    Manages filing of documents and records according to policies and regulatory standards.
•    Training and Guidance:
o    Provide training and mentorship to team members and departments on change control procedures, risk assessment, and compliance requirements.
o    Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities.

Your Profile

•    Bachelor’s degree in Life Sciences, Engineering, or a related field.
•    3+ years of experience in change control within a regulated environment, ideally in medical devices or pharmaceuticals.
•    Strong knowledge of FDA QSR, ISO 13485, and cGMP requirements.
•    Experience with electronic Quality Management Systems (eQMS) and document control.

Our Offer