Quality Assurance Specialist

hace 2 semanas

Barcelona, Barcelona, España Galderma A tiempo completo

Job Title: Quality Assurance Specialist - Biologics

Location: Hybrid, Barcelona

Job Description:

This person will work to oversee and execute product release activities in compliance with regulatory requirements and global standards. The main scope of this position will be covering the Sterile Manufacturing Operations, collaborating with expertise in QA functions, including release activities, sterile production, documentation, data integrity, and regulatory compliance.

Key Responsibilities:

  • Release Activities: Oversee and execute product release activities in compliance 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 abreast of 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:

  • You will be working for an organization that values diversity and inclusion and believes that reflecting the perspectives of our diverse customer base will lead to better outcomes.
  • You will receive a competitive compensation package with a bonus structure and extended benefits.
  • You will be able to work in a hybrid work culture.
  • You will participate in feedback loops, during which a personalized career path will be established.
  • You will be joining a growing company that believes in ownership from day one, where everyone is empowered to grow and take on accountability.

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