Quality Assurance Specialist

Overview:

Our client is seeking a dedicated and detail-oriented Quality Assurance Specialist to join their team in Germany. This role involves ensuring compliance with quality standards through the qualification and validation of equipment, facilities, utilities, and processes. The ideal candidate will have a strong background in quality systems and a commitment to fostering a culture of excellence.

Key Responsibilities:

• Conduct qualification and validation activities for equipment, facilities, utilities, and processes.
• Perform risk analyses for new production processes and create qualification plans.
• Develop and review qualification and validation documents, including URS, DQ, IQ, OQ, and PQ.
• Execute temperature mappings and maintain the site qualification master plan.
• Develop and review SOPs, work instructions, and forms.
• Maintain and monitor a register of equipment requiring qualification and validation.
• Collaborate with other departments to drive projects forward effectively.
• Discuss validation requirements for new orders with customers.
• Assist with regulatory inspections, customer visits, and audits related to qualification and validation.
• Implement and monitor defined quality objectives.
• Manage change control and deviations, assigning corrective actions and ensuring timely implementation.
• Conduct periodic reviews, re-qualifications, and ongoing process reviews.
• Train and support employees on qualification and validation topics.

Qualifications and Experience:

• 2-3 years of experience in a quality systems-related role, preferably within the pharmaceutical or packaging industry.
• Proven expertise in qualification and validation of rooms, equipment, processes, and utilities.
• Strong knowledge of GMP requirements and Quality Assurance inspection standards.
• Familiarity with risk analysis methodologies.
• Ability to conduct temperature mappings effectively.

Skills:

• Fluent in business English and German (both written and spoken).
• Excellent interpersonal and teamwork abilities.
• Strong commitment to Quality Assurance principles.
• Analytical mindset with high attention to detail.
• Self-motivated and highly organized.