Quality Assurance Expert (m/f/d)

Contract start date: Immediately

Contract end date: 31.12.2026

Responsibilities:

• Act as Quality single point of contact for the activities assigned
• Author, review and approve deliverables included but not limited to, such a SOPs, gap assessments, risk assessment, cleaning documents, WI)
• Coordinate, review and approve quality records included but not limited to, such as deviations, CAPAs, change controls, qualification and validation documentary) related to the manufacturing processes in Trackwise and KNEAT
• Participate and provide support to Growth Projects 41X operational departments in alignment with cGMP
• Serve as QA oversight to ensure GMP compliance within manufacturing activities.
• Support SMEs during investigation, included but not limited, such as root cause analysis, impact assessment, action plan implementation.
• Participate in quality systems improvements projects and lead lean improvement projects to ensure efficiency in alignment with global and local standards
• Monitor local and global meetings as well as project progress to ensure efficient and effective communication on project status
• Liaise with external partners/customers to set up a release strategy for deliverablesin alignment with corporate standards as well as global and local standards
• Deliver expertise in all matters concerning cGMP compliance as required
• Define, manage and report Quality Key Performance Indicators (KPI), as needed
• Perform other agreed activities as assigned by the line manager
• Execute, improve and maintain the Quality Oversight concept within DPS manufacturing
• Active participation in audits (internal and external) and inspections as needed per audit/inspection plan
• Deputize Team Lead QA Operations – Growth Project as required

Requirements:

• University or academic degree (Master or Ph.D.) in Chemistry, Biology, Pharmacy or equivalent
• 5-10 years of experience Professional experience in Quality Assurance or Quality Control in a manufacturing environment within Pharmaceutical Industry
• Superior problem solving, decision making and planning skills
• Sets clear priorities for task for him/herself and the team
• Customer oriented and collaboration with Process Unit team
• Sound knowledge of cGMP and regulatory compliance of all relevant operations in the Process Unit
• Excellent English skills (spoken and written), German skills an advantage