Quality Specialist Consultant


Copenhagen
Contract
Negotiable
Quality
CR/559115_1756479971
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)

FAQs

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