Inspection Manager - Gent, België - MindCapture

MindCapture

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

INSPECTION MANAGER

Biotech
GhentWHAT IS OFFERED

We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.

We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance.

Depending on your seniority, a car may be provided.

We provide personalised training to let you grow in the area of

What you like to do
What you are good at
Where and how you want to have an impact

ABOUT THE COMPANY

MindCapture collabs with a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.

They have established immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.

Together, we are looking to strengthen their quality team with a motivated and experienced Inspection Manager with a strong quality mindset.

The Inspection Manger will oversee the complete inspection program; manage GxP inspections with focus on health authority inspection and provide expert, timely and risk-based guidance in line with regulations & business needs related to inspection readiness activities.

Cross functional global collaboration with multiple teams is key to ensure that inspection activities are planned and executed in accordance with internal procedures in order to maintain inspection ready at all times.
Deliver planning for inspection readiness activities, inspection management training, developing, and maintaining inspection management processes and development of inspection management tools and systems.
Facilitate the needs of the inspection team for health authority inspections. Provide continuous awareness to employees on inspection related matters, as and when needed.
Work with Global Quality. Facilitate inspection readiness, requests for information/documentation, and inspection response activities.
Stay on top of all inspectionrelated requests/actions/observations in order to streamline responses throughout different inspections.
Manage CAPAs associated with findings/observations identified during health authority inspection and internal audits. Oversee inspectionrelated Lessons Learned and support implementation of its actions.
Maintain prediction of inspections and report status of health authority inspections. This includes reporting inspection activity, findings/observations, metrics, and relevant insights such as inspection history, SAE, etc.
Assist in the preparation of inspection risk assessments for senior management and key stakeholders so they are apprised key risk prior to an inspection and that appropriate corrective action plans are implemented in a timely manner.

REQUIRED COMPETENCES & SKILLS

Pharmaceutical background preferred with strong knowledge of the global health authority regulations (e.g., FDA, EMA, PMDA); local requirements and GxP.
Knowledge and experience of inspection management processes with ability to drive inspection preparedness and response actions.
Strong communication, organization and networking skills.
Excellence in leadership.
8+ years of experience in quality & compliance activities including audit and inspection support.
5+ years of experience in regulated industry or equivalent.
Ability to travel up to 25%.