Quality Assurance Specialist

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world.

With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. We have established a Global Capability Center in Barcelona to support Galderma’s growth trajectory and our global commercial and functional teams. Located in the upscale Eixample district in the heart of the city, it offers the possibility for professional career development through exposure to global and cross-functional projects.

We are currently seeking a dynamic and experienced Quality Assurance (QA) Specialist with 3-8 years of experience in the medical device or pharmaceutical industry. The ideal candidate will have expertise in various QA functions, including complaint management, release activities, sterile production, documentation and regulatory compliance. The position is within the External Supplier Organization (ESO) for Sterile Products and You will work closely with ESO suppliers.

• Quality Systems:
  Contribute to the development, implementation, and maintenance of robust quality systems, including complaint management, deviation management, change control, CAPA, and risk management processes. Main responsibilities for QMS will be complaint management.
• Release
  
  Activities:
  
  Execute product release activities in compliance with regulatory requirements and company standards. Ensure timely and accurate release of pharmaceutical products for distribution.
• Sterile Production:
  Provide QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring. Ensure adherence to cGMP guidelines, regulatory standards and applicable ISO standards.
• Documentation Management:
  Manage and review quality documentation, including batch records, standard operating procedures (SOPs), risk management, validation protocols, and reports. Ensure documentation complies with regulatory requirements, ISO
  13485, MDR and internal quality standards.
• Regulatory Compliance:
  Stay abreast of regulatory requirements and industry best practices related to quality assurance. Ensure compliance with FDA regulations, international standards such as applicable ISO standards, and company policies.
• Audits and Inspections:
  Support internal and external audits and regulatory inspections. Support Due Diligence audits for initial qualification of suppliers. Prepare and review audit documentation, respond to audit findings, and implement corrective and preventive actions as necessary.
• Continuous Improvement:
  Identify opportunities for process improvement and quality enhancement. Participate in quality improvement initiatives and projects to optimize quality systems and operational efficiency.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 5-8 years of experience in a quality assurance role within the medical device, pharmaceutical or regulated industry.
• Fluency in written and verbal English, any other language is an asset.
• Strong operational knowledge of medical device or pharmaceutical manufacturing processes, including production of sterile biological drugs, terminally sterilized and/or aseptically filled products.
• Proficiency in documentation management.
• Familiarity with regulatory requirements, including cGMP, FDA regulations, ISO
  13485 & MDR and international guidelines.
• Excellent communication Ability to work independently and collaboratively in a dynamic, fast-paced environment.

• Pharmacist or Master’s degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology, Life Science or another relevant scientific or engineering discipline.
• Previous experience in reviewing supply agreements and manage quality agreements.
• Previous…