Head of Quality Assurance Pharma Solutions (100%)
Auf einen Blick
- Veröffentlicht:11 Dezember 2024
- Pensum:100%
- Vertragsart:Festanstellung
- Sprache:Englisch (Fliessend), Deutsch (Fliessend)
- Arbeitsort:Maienbrunnenstrasse 1, 8908 Hedingen
With approximately 480 employees, KLK Kolb is one of the leading alkoxylation companies in Europe and offers a wide range of surfactants, chemical specialties, paper process chemicals and customer-specific products for various industries. KLK Kolb is a member of the global KLK OLEO Group. We sell our products worldwide and currently have three manufacturing sites in the heart of Europe (Hedingen/CH, Moerdijk/NL, and Delden/NL).
Are you an independent, entrepreneurial, and result-oriented personality who would like to work in an internationally growing company? Then we look forward to receiving your application documents for the position of
Your new role
- 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.)
Desired skills and experience
- Degree from University of Applied Science (FH) or University/ETH qualified in a natural science discipline (Pharmaceutical Science, Biotechnology, Chemistry, etc.). Advanced degree preferred
- Minimum of 5 years’ experience in quality assurance within the pharmaceutical industry. Preferable with knowledge of guidelines for excipient production (e.g. Excipact, IPEC, ICH) and basis knowledge of GMP, GDP and GWP.
- Strong knowledge of regulatory requirements and industry standards
- Proven track record of leading and developing high-performing teams
- Excellent communication and interpersonal skills
- Strong analytical and problem-solving skills
- Fluency in English and German, other languages are a plus
- Experience with quality management systems and tools and strong project management skills
- Willingness to travel in Europe (case-by-case)
- Demonstrated commitment to continuous improvement and quality excellence
Our offer
- A challenging, versatile, and responsible job in a rapidly growing international company.
- Working place/employment is Hedingen, Switzerland
- A professional, established organization with an open, international, and creative working environment
- Personal and professional development opportunities
- Attractive employment conditions
We are interested in a long-term, successful collaboration. You too? We are looking forward to receiving your application.
Kontakt
- Marianne PantliHR Manager