Job Description Summary Our Palafolls site is recruiting!
Job Description Our goal is not just to increase access, but to do so in a sustainable and responsible way: finding the right balance between guaranteed quality, reliable supply and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality to protect our environment (carbon footprint, natural resources), as well as to champion diversity, equity and inclusion across our company and beyond.
As QA Compliance Specialist & QA Coordinator Nitrosamines, you will provide QA oversight to Nitrosamines GQS Palafolls activities. Ensure that all the activities and documentations performed are according to the current requirements.
Your responsibilities will include: Oversees the Quality Plan on site and its implementation.Support audits and regulatory inspections during the execution and preparation the answers to the possible observations or finding detected.Ensures compliance and drives the implementation of compliance alerts in collaboration with key stakeholders.Provides QA oversight to complex qualification activities and projects to ensure activities are in compliance with GMPs, corporate policy, local procedures and regulatory expectations.Keeps the site up to date with new compliance requirements applicable to Nitrosamines GQS and oversees Nitrosamines GQS activities. Coordinates review and approvals of procedures, methods, analytical method validations and transfers, local preparation or re-standardization of working standards, risk assessments, deviations, OOS/OOE, CAPAs, change requests, SST reports, analytical reports, certificates of analysis, periodic calibration/verification/requalification of the equipment, etc.Support CR coordinator activities.Lessons learned and best practice in relation to Quality Systems, compliance and proactivity compliance on site within NTO Network focused on Nitrosamines GQS activities.Governance of the implementation of the "Compliance team in GMP Walkthroughs" in Nitrosamines GQS to ensure GMP compliance.Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs.Support e-Compliance activities.Support reporting of KPI's related to compliance related to Nitrosamine GQS.Support review and control of key KPIs on site related to Nitrosamine GQS.Participate in and support escalation calls and coordinate follow ups where necessary.Support on report preparation / presentations where Nitrosamine GQS related documentation is required.Ensures the implementation of Sandoz Global procedures including related monitoring and reporting processes.Ensures GxP procedures and processes are up to date, robust, aligned and fit for purpose.Support for the business Experts on the Quality Systems.Key user of Quality systems defined: GX_QEMBack-up in QA role in QC, based on the QC routine tasks oversight, procedures, reports & investigations review documents, review and approval of OOS.Data Integrity Lead for Nitrosamines QC.What you'll bring to the role: University degree in life sciences, preferably in pharmacy or chemistry or equivalent.Fluent Spanish and EnglishOver 3 years' experience in Quality Assurance within the pharmaceutical industry or equivalent preferable in FDA regulated environment (sterile, API) and knowledge in EU and US regulations (GMP, ICH, Pharmacopeia).Sound experience with GMPKnowledge of Quality control activitiesGood knowledge of Data Integrity and related computerized systems compliance.Experience preferred of Health Inspection Readiness and implementation within Pharmaceutical Industry.Quality Assurance/ cGMP EU and US requirements (Self-inspections, Walkthroughs, GMP training to people in the site)Good knowledge to use Quality Systems (CAPAS, Change Control, Deviation Handling & Documentation) as well as KPI's systems.Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is (y)ours to shape!
Commitment to Diversity & Inclusion: Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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