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Senior Quality Assurance Specialist
hace 1 mes
Company Overview
Sandoz, a leader in the global generic and biosimilar medicines sector, aims to improve access to affordable healthcare. With a strong commitment to innovation and sustainability, we strive to make a positive impact on people's lives.
Job Description
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at our Palafolls site in Barcelona, Spain. As a key member of our quality assurance team, you will be responsible for ensuring that all activities and documentation performed at the site meet the highest standards of quality and compliance with regulatory requirements.
Your Responsibilities:
- Oversight of the Quality Plan and its implementation;
- Supporting audits and regulatory inspections, preparing answers to observations or findings detected;
- Ensuring compliance and driving the implementation of compliance alerts in collaboration with key stakeholders;
- Providing QA oversight to complex qualification activities and projects to ensure activities are in compliance with GMPs, corporate policy, local procedures, and regulatory expectations;
- Maintaining the site up-to-date with new compliance requirements applicable to Nitrosamines GQS and overseeing Nitrosamines GQS activities;
- Coordinating review and approvals of procedures, methods, analytical method validations, and transfers;
- Support CR coordinator activities;
- Liaising with the business Experts on Quality Systems;
- Key user of Quality systems defined: GX_QEM;
Requirements:
- University degree in life sciences, preferably in pharmacy or chemistry or equivalent;
- Fluent Spanish and English;
- Over 3 years' experience in Quality Assurance within the pharmaceutical industry or equivalent, preferably in an FDA-regulated environment (sterile, API) and knowledge in EU and US regulations (GMP, ICH, Pharmacopeia);
- Solid understanding of GMP and Data Integrity principles;
- Good knowledge of Quality control activities;
- Experience preferred of Health Inspection Readiness and implementation within the Pharmaceutical Industry;
- Quality Assurance/cGMP EU and US requirements (Self-inspections, Walkthroughs, GMP training to people in the site).
Benefits
As a Senior Quality Assurance Specialist at Sandoz, you can expect a competitive salary of €45,000 - €65,000 per year, depending on your qualifications and experience. Our company offers a dynamic and inclusive work environment where diversity is valued and personal growth encouraged.
Why Join Us?
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. By joining our team, you will contribute to shaping the future of healthcare and making a positive impact on people's lives.