Sr Quality Assurance Expert.

This position is an interface function within the areas of Quality Assurance and Regulatory Affairs with responsibilities in external, internal inquiries and questionnaires regarding product safety, regulatory, legal and normative requirements for the product portfolio in active ingredients.

Responsibilities

• Support in setting up and managing the GMP management system for the manufacture of excipients (excipact) within the overall management system
• Compliance with the specifications of the integrated management system, creation and maintenance of the documents relevant to Quality Assurance/Regulatory Affairs using the IMS software
• Commissioning and evaluation of toxicological studies and further measurements of specific products and derivation of the consequences
• Participation in the creation of regular reports and statistics for monthly reports, management reviews, product quality reviews
  Control of relevant production and quality records
• Monitoring of related regulations and derivation of necessary measures
  Support for the harmonization of activities and documentation for the European sites
• Support in the training program for employees, implementation and further development of training courses and success checks
• Support and participation in creating, maintaining and coordinating relevant documents such as product specifications and statements in cooperation with supervisors, product management and other bodies
• Assignment as an auditor for internal audits, supplier audits and cross-audits within the Group in audit planning and implementation, reporting and tracking of measures
• Participation in the stability program for active ingredients and excipients

Requirements

• Completed degree in chemistry, life sciences or similar
• 5 years of professional experience in Quality Assurance/Regulatory Affairs in a similar production/ manufacturing industry
• Sound knowledge or experience in GMP and/or Excipact
• Communicative and customer-oriented personality, the requirements of authorities and customers can contribute convincingly in interdisciplinary teams
• Team player with a pragmatic way of working and strong analytical skills
• Confident handling of MS Office applications and ERP systems (SAP)
• Very good knowledge of German and English (oral and written)

In return, my client offers a great career in a well-established organisation that encourages a creative working atmosphere with an attractive salary package for the ideal candidate.