Beschreibung
For our client in the healthcare sector we`re looking for a Project Quality Assurance Representative (m/w/d) to facilitate the introduction of a new product including new building, clean rooms, utilities, and multiple new production equipment and product validation and to support qualification and validation activities has been defined.Key data:
start: April 22
end: April 23
capacity: 100%
location: Remote / regularly onsite availablility as well needed (Friesoythe)
Responsibilities:
Project Quality Assurance Representative related to qualification and validation activities for a new production building and lines in cooperation with Engineering department, Qualification Department, Production and the
Laboratories for following subprojects:
- New Building and (Clean)rooms
- Utilities
- Multiple new production equipment
- Manufacturing Processes
- Analytical and microbiological method validations
- Computer system validations
Specifically:
• Review of project related documentation against
- Design Qualification (URS, FRS, FAT, SAT) and Commissioning
- Risk Assessments (e.g. FMEA)
- Installation-, Operational- and Performance Qualification
- Process and Method validations
- Documents for regulatory purposes
- Assessments
- Change controls, Deviations etc.
• Apply professional interdisciplinary project teamwork supporting the team with Engineering department, Qualification Department, Production, EHS and the Laboratories in questions regarding GMP-compliant solutions
• Support root cause analyses and troubleshooting activities in case of deviations from Quality Assurance Perspective
• Support creation, assessment, and completion of change control cases from Quality Assurance Perspective.
• Contact to the overall project leaders in different departments and within the global project team to support from Quality Assurance Perspective.
Skills/Qualification:
- Professional experience in pharmaceutical Quality Assurance
- Exceptional knowledge about GMP-requirements and pharmacopoeia (Ph. Eur., USP)
- Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods
- knowledge in computer system validation preferred
- Project management knowledge, leadership capabilities with respect to quality topics
- Experience with implementation of new pharmaceutical buildings and new line preferred
- Strong soft skills for the coordination and motivation of interdisciplinary teams in a matrix structure
- Exceptional degree of team spirit, flexibility and robustness
- Proficient communication skills in an English-speaking project environment, good German language skills in spoken and written
(Out-of-Scope:
• Quality Assurance activities not related to the project.
• Change Management (not acting as Quality Representative).
• Deviation Management (not acting as Quality Representative).
• No administrative work (e.g. not acting as formal SOP-Owner/Approver) )