Investigation of laboratory deviations and oos/oot
The role integrates into the Quality Control Laboratory team providing technical support and leading continuous improvement projects to ensure compliance with regulatory standards and global quality norms
Job Summary
The role integrates into the Quality Control Laboratory team providing technical support and leading continuous improvement projects to ensure compliance with regulatory standards and global quality norms.
The position involves coordinating corrective and preventive actions, investigating laboratory deviations, and maintaining communication with external sites and global teams to ensure traceability and alignment.
The candidate will also be responsible for data analysis, preparation of quality reports and dashboards, and active participation in internal and external audits.
Matching Summary
The role integrates into the Quality Control Laboratory team providing technical support and leading continuous improvement projects to ensure compliance with regulatory standards and global quality norms.
Skills & Requirements
Must-have
Quality control laboratory support
Regulatory compliance with BPF/GMP and GLP
Investigation of laboratory deviations and OOS/OOT
Implementation and validation of analytical methods
Data integrity and quality metrics analysis
Coordination of CAPA and non-conformity management
Nice-to-have
Lean Six Sigma Green Belt certification
Experience with microbiological quality control
Strong verbal and written communication skills
Project management and root cause analysis
Collaborative and continuous improvement focus
Key Requirements
Bachelor’s degree in Pharmacy, Chemistry or related
Minimum 5 years experience in Quality Control or Analytical Development
Preferred postgraduate qualification in Quality
Advanced English proficiency desirable
Lean Six Sigma Green Belt or equivalent certification preferred