Ops investigator

We are currently looking for a OPS Investigator for one of our life sciences client in the region of Ghent:

• Lead and support (cross-) departmental investigations and risk assessments by applying appropriate root cause analysis tools and risk assessment methodologies in accordance with cGMP regulations and internal quality systems
• Identify appropriate and strong CAPA actions and effectiveness checks linked to non-conformances, and lead, support, and execute the implementation of CAPA actions
• Build strong partnerships in a matrixed environment by liaising with different (cross-) functional teams such as Operations, QA, MS&T, QC (IPL), Supply Chain, Engineering, as well as external collaborators to solve issues, drive improvement, and ensure consistent product quality
• Operate with a high degree of independence, seeking managerial input for complex or non-routine matters
• Provide support during internal and external audits, including preparation of documentation

Required profile:

• A minimum of a Master's degree in (bio)-Engineering, Science, Pharmacy or related field or equivalent experience required
• 1-3 years of experience with handling and writing non-conformances/investigations within a cGMP or ATMP environment in the biotech/biopharma industry. Prior experience in manufacturing or quality is considered an advantage
• Excellent scientific writing skills with attention to detail
• Excellent communication skills
• The candidate must be able to manage shifting priorities, handle multiple tasks simultaneously, and be flexible to go the extra mile to meet critical deadlines in a fast paced and dynamic environment
• Flexible mindset capable to deal with ambiguity, and respond quickly, energetically, and enthusiastically to changes
• Positive and pro-active attitude, able to work in a team environment