Senior specialist QC Compliance

ph3Aperçu /h3 pThe Senior Specialist QC Compliance supports the Manager QC Compliance Support in ensuring that QC processes are compliant with regulatory and Incyte requirements, and in contributing to their continuous improvement based on industry best practices. The activities include support related to key QC compliance processes, including deviations, investigations, CAPA, change controls, data integrity, analytical software validation and audit trail review, periodic reviews, periodic trending reports, training, inspection and audit preparation, regulatory and pharmacopoeial surveillance, and quality process metrics reporting. The role contributes to periodic review and QC trending reports, including Out-of-Specification (OOS), invalid results, and Environmental Monitoring (EM) and Utilities (UTY) trends. Additional responsibilities include QC supplies and sample management and QC material release. /p h3Duties and Responsibilities /h3 ul liAct within compliance and legal requirements as well as within company guidelines /li liSupport the QC team as a compliance subject matter expert for QC. /li liContribute to the organization of QC Compliance Support activities by coordinating assigned responsibilities, ensuring planning and timely delivery, managing priorities, escalating risks and issues, and supporting service improvement, simplification and automation initiatives. /li liSupport the implementation of quality compliance initiatives in the department in collaboration with QA and the Bioplant quality champion community. Provide guidance and support to team members on quality compliance matters, such as deviation and change management. Contribute to the department's inspection readiness within the QC Compliance Support scope. /li liSupport the QA Champion for QC in driving a high level of quality and compliance in the department: monitor and report quality compliance indicators for QC. /li liManage, investigate and close quality events and deviations in support of QC SMEs. /li liSupport and coordinate QC SMEs for the timely and effective completion of deviations, non-conformances, investigations, change controls, CAPAs and periodic reviews. /li liEnsure delivery of the Data Integrity Plan, including DI risk-analysis assessments and action plans, and periodically report status and progress to the leadership team. Support escalation as required. /li liContinuously improve the data integrity knowledge base and understanding: detect and mitigate DI risks by working with SMEs, identify training needs and deliver training. /li liContribute to periodic QC compliance and laboratory trending reports, including OOS, invalid results, EM and utilities monitoring trends; compile and review data, identify negative trends, support investigation and escalation, and propose corrective or preventive actions. /li liAct as a QC contributor to EM and utilities monitoring in collaboration with the Microbiology Manager, Manufacturing, Engineering and QA Engineering; perform the monthly review of EMS alarms for QC and support follow-up of trends and associated actions. /li liPerform QC equipment periodic reviews and support new QC equipment qualification, including URS drafting, risk-analysis review, and qualification protocol and report review. /li liFollow up QC equipment work orders in the GMAO and review related documentation, including requalification protocols, calibration certificates, interventions and preventive maintenance records. /li liContribute to QC supplies and sample management activities, including receipt, aliquoting, review, recording in LIMS, storage and shipment. /li liPerform QC material release activities. /li liPerform compliance tasks in LabWare, including review of QC investigations and changes to instrument status. /li liAuthor, review, approve and maintain the lifecycle of relevant Standard Operating Procedures, Work Instructions and other quality documents related to areas of responsibility, and support other areas as required. /li liLead and contribute to the preparation of health authority inspections, internal and corporate audits, and responses to observations within the QC Compliance Support scope. /li liSupport the assessment of regulatory and pharmacopoeial surveillance linked to QC activities. /li liProvide training and guidance to team members on compliance, data integrity and QC processes, as required. /li liContribute positively to a strong culture of proactive quality, continuous improvement, business integrity and ethics. /li /ul h3Requirements /h3 ul liCollaborative mindset focused on teamwork. /li liFrench and English (good level - C1). /li liAbility to work in a fast-paced, highly regulated environment. /li liAbility to build trust and foster a collaborative and inclusive environment and relationships. /li liDemonstrated ability to organize activities, manage priorities, support escalation and contribute to improvement initiatives. /li liExperience in troubleshooting, investigation and root cause analysis in a cGMP environment required. /li liExperience with Quality systems such as Deviation, CAPA and Change Control systems required. /li liHands-on experience with equipment software qualification, analytical software audit trail review and QC equipment periodic review. /li liExperience with LabWare, LIMS and GMAO/CMMS systems preferred. /li liDemonstrated hands-on Quality Control experience, typically 3-5 years, ideally in a biotech, pharmaceutical or chemical environment. /li /ul pBiotechnology or pharmaceutical MSc degree preferred (e.g., Swiss HES, University, Engineering School), or equivalent relevant experience in the biotech industry. /p pDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /p /p #J-18808-Ljbffr