.Job Description SummaryOur Palafolls site is recruiting!Job DescriptionOur 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.
- Actively collaborate with other Nitrosamines GQS to support and align QA requirements.
- Quality Management Systems support for maintaining, managing and continuously improve the site Quality systems, ensuring compliance with Sandoz Global procedures and local Regulatory rules, in collaboration with all site departments and the Global Sandoz QMS Network.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