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Quality Assurance Specialist

hace 2 meses

Barcelona, Barcelona, España Galderma A tiempo completo
Job Title: Quality Assurance Specialist

Galderma is a leading dermatology company that is committed to advancing the field through innovation and excellence. We are seeking a highly skilled Quality Assurance Specialist to join our team in Barcelona.

Job Summary

The Quality Assurance Specialist will be responsible for overseeing and executing product release activities in compliance with regulatory requirements and global standards. This role will involve providing QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring.

Key Responsibilities
  • Release Activities: Ensure that product releases are conducted in accordance with regulatory requirements and company standards.
  • Sterile Production: Provide QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring.
  • Documentation Management: Manage and review quality documentation, including batch records, standard operating procedures (SOPs), validation protocols, and reports.
  • Data Integrity: Implement and maintain data integrity controls to ensure the accuracy, completeness, and reliability of quality data.
  • Regulatory Compliance: Stay up-to-date with regulatory requirements and industry best practices related to quality assurance.
  • Quality Systems: Contribute to the development, implementation, and maintenance of robust quality systems, including deviation management, change control, CAPA, and risk management processes.
  • Audits and Inspections: Support internal and external audits and regulatory inspections.
  • Continuous Improvement: Identify opportunities for process improvement and quality enhancement.
Requirements
  • Effective experience in a quality assurance role within the pharmaceutical or regulated industry.
  • Experience in Batch Release is a must.
  • Biologics experience.
  • Strong operational knowledge of pharmaceutical manufacturing processes, including sterile production.
  • Proficiency in documentation management and data integrity principles.
  • Familiarity with regulatory requirements, including cGMP, FDA regulations, and international guidelines.
  • Excellent communication, problem-solving, and decision-making skills.
  • Ability to work independently and collaboratively in a dynamic, fast-paced environment.
  • Previous experience in leading or participating in regulatory inspections and audits.
What We Offer
  • A competitive compensation package with bonus structure and extended benefit package.
  • A hybrid work culture that allows for flexibility and work-life balance.
  • Opportunities for professional growth and development, including training and mentorship programs.
  • A dynamic and inclusive work environment that values diversity and promotes a culture of ownership and accountability.