Quality Assurance Specialist - BiologicsLocation: Hybrid, BarcelonaJob 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.Skills & Qualifications: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 in return:You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.You will receive a competitive compensation package with bonus structure and extended benefit package.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 to take on accountability.Process steps:Send your CV in English.If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.The next step is a virtual conversation with the hiring manager.The final step is a panel conversation with the extended team.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.About usGalderma 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.
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