Senior specialist QC Compliance

Aperçu

The 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.

Duties and Responsibilities

• Act within compliance and legal requirements as well as within company guidelines
• Support the QC team as a compliance subject matter expert for QC.
• Contribute 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.
• Support 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.

• Support 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.
• Manage, investigate and close quality events and deviations in support of QC SMEs.
• Support and coordinate QC SMEs for the timely and effective completion of deviations, non-conformances, investigations, change controls, CAPAs and periodic reviews.
• Ensure 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.

• Continuously improve the data integrity knowledge base and understanding: detect and mitigate DI risks by working with SMEs, identify training needs and deliver training.
• Contribute 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.
• Act 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.
• Perform QC equipment periodic reviews and support new QC equipment qualification, including URS drafting, risk-analysis review, and qualification protocol and report review.
• Follow up QC equipment work orders in the GMAO and review related documentation, including requalification protocols, calibration certificates, interventions and preventive maintenance records.
• Contribute to QC supplies and sample management activities, including receipt, aliquoting, review, recording in LIMS, storage and shipment.
• Perform QC material release activities.
• Perform compliance tasks in Lab Ware, including review of QC investigations and changes to instrument status.
• Author, 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.
• Lead and contribute to the preparation of health authority inspections, internal and corporate audits, and responses to observations within the QC Compliance & Support scope.
• Support the assessment of regulatory and pharmacopoeial surveillance linked to QC activities.
• Provide training and guidance to team members on compliance, data integrity and QC processes, as required.
• Contribute positively to a strong culture of proactive quality, continuous improvement, business integrity and ethics.

Requirements

• Collaborative mindset focused on teamwork.
• French and English (good level - C1).
• Ability to work in a fast-paced, highly regulated environment.
• Ability to build trust and foster a collaborative and inclusive environment and relationships.
• Demonstrated ability to organize activities, manage priorities, support escalation and contribute to improvement initiatives.
• Experience in troubleshooting, investigation and root cause analysis in a c GMP environment required.
• Experience with Quality systems such as Deviation, CAPA and Change Control systems required.
• Hands-on experience with equipment software qualification, analytical software audit trail review and QC equipment periodic review.
• Experience with Lab Ware, LIMS and GMAO/CMMS systems preferred.
• Demonstrated hands-on Quality Control experience, typically 3-5 years, ideally in a biotech, pharmaceutical or chemical environment.

Biotechnology or pharmaceutical MSc degree preferred (e. g., Swiss HES, University, Engineering School), or equivalent relevant experience in the biotech industry.

Disclaimer: 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.

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