Quality Assurance Specialist

Galderma Services Spain, S.L.; Alby-sur-Chéran; Sur place; EUR 42 000 - 65 000; Plein temps

Résumé du poste

Galderma seeks a QA Specialist with 3-8 years in the medical device or pharmaceutical industry to join the External Supplier Organization in Barcelona. You will contribute to quality systems and regulatory compliance across the product lifecycle.

Responsibilities include release activities, sterile production oversight, documentation management, and ensuring adherence to cGMP, ISO13485 and MDR. Fluency in English is required.

Qualifications

• 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 knowledge of production of sterile products, cGMP, FDA regulations, ISO13485 & MDR.

Responsabilités

• Contribute to development, implementation and maintenance of quality systems (QA, deviation, CAPA, risk management).
• Oversee product release activities in line with regulatory requirements.
• Provide QA oversight for sterile manufacturing operations and environmental monitoring.

Connaissances

English fluency

Communication

Independent worker

Team collaboration

Formation

Bachelor's degree in Pharmacy

Outils

Quality Management System (QMS)

Description du poste

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.

Key Responsibilities

• 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, ISO13485, 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.

Required Qualifications

• 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, ISO13485 & MDR and international guidelines.
• Excellent communication
• Ability to work independently and collaboratively in a dynamic, fast-paced environment.

Preferred Qualifications

• 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 experience in leading or participating in regulatory inspections and audits.
• Problem-solving, and decision-making skills.

What we offer in return

You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. In ESO organization nearly 60 employees work together in a global environment on our world leading brands such as Nemluvio and Sculptra. We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged.

Next steps

• The selection process is ongoing and the role may be filled prior the last application date.
• If your profile is a match, we will invite you for a first virtual conversation with the recruiter
• The next step is a virtual conversation with the hiring manager.
• The second step is an interview with SRT Director.
• The final step is an interview with Head of Global Supply.

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information go to www.galderma.com/careers