Quality Assurance Specialist
hace 1 mes
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, 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're in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold 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.
Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma's Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.
Job Title: Quality Assurance Specialist
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.
Skills & Qualifications
- Effective experience in a quality assurance role within the pharmaceutical or regulated industry.
- 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.
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