Quality Specialist Consultant

About the Role

We are looking for a detail-oriented and proactive Quality Specialist to join a key pharmaceutical client in Copenhagen. You will play a critical role in ensuring that their products meet the highest standards of quality, safety and regulatory compliance throughout the development and manufacturing lifecycle.

Key Responsibilities

• Develop, implement, and maintain QMS in alignment with GxP standards.
• Conduct internal audits of manufacturing processes, laboratory procedures, and documentation to ensure compliance and identify areas for improvement.
• Review and approve batch records, validation protocols and analytical testing reports.
• Investigate and resolve complaints, non-conformances, and deviations, implementing CAPAs to prevent recurrence.
• Oversee the validation and qualification of equipment, processes, and analytical methods.
• Provide training to staff on quality standards and regulatory requirements.
• Participate in risk assessments and implement mitigation strategies to ensure product quality and patient safety.

Qualifications & Experience

• Bachelor's or Master's degree in Chemistry, Biology, or a related field.
• Minimum 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong knowledge of European pharmaceutical legislation, EMA guidelines, and ISO standards.
• Excellent analytical, organisational, and communication skills.
• Fluent in English; Danish language skills are an advantage.

Contract

• Start date: 20th September
• 12 month contract
• 40 hours per week
• Hybrid (must be based in Copenhagen)