Overview
OPS Investigator Jobs in Ghent, Flemish Region, Belgium at Arcadis
Title: OPS Investigator
Company: Arcadis
Location: Ghent, Flemish Region, Belgium
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
