Your mission
- Create, update and enforce quality assurance policies and procedures to ensure compliance with ISO9001:2015, EXCiPACT and IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients within the overall quality management system for the KLK Kolb Group.
- Ensure all operations comply with relevant industry standards for excipients and continuously improve product quality and operational efficiency in collaboration with relevant departments (e.g. operations and R&D)
- Lead, mentor, and develop quality assurance team
- Oversee quality assurance process, including material receipt, analysis, release, rejection, storage, and usage
- Conduct regular cross-audits within the KLK Oleo Europe to ensure compliance and identify areas for improvement
- Prepare and lead customer and supplier audits in accordance to industry standards and agreed quality standards with the relevant partner
- Identify and manage quality-related risks and develop mitigation strategies as needed
- Ensure timely resolution of quality issues (e.g. out-of specification) and customer complaints for pharmaceutical excipients and in collaboration with involved departments
- Develop and provide trainings for all staff with relation to GMP for pharmaceutical excipients; ensure up-to-date trainings
- Maintain accurate and up-to-date documentation of all quality assurance activities within the business unit of pharma solutions.
- Work closely with manufacturing, R&D, product management, regulatory affairs and supply chain teams to ensure product quality of pharmaceutical excipients
- Prepare, submitted and support documentation for drug master files, CEP in collaboration with internal stakeholder and regulatory bodies (e.g. FDA, EMA, CFDA etc.)