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Head Of Quality Assurance Pharma Solutions

Head Of Quality Assurance Pharma Solutions

Kolb Distribution AGHedingen, CH
Vor 9 Tagen
Stellenbeschreibung

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.

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