SUMMARY:
The role will support the Quality oversight of Engineering and CSV activities at Incyte large scale biological manufacturing facility at Yverdon-les-Bains, Switzerland.
The role will ensure QA deliverables related to classified rooms and utilities qualification, maintenance, calibration, equipment qualification, system validation and overall operational GMP readiness in accordance with cGMP regulations, company policies, and regulatory requirements.
The role will ensure a strong collaboration with other Bioplant functions and will promote compliance, continuous improvement and Quality culture.
DUTIES AND RESPONSIBILITIES
- Provide Quality Assurance oversight for equipment and utilities throughout their lifecycle (including the Commissioning & Qualification, Calibration and Maintenance activities).
- Review and approve qualification documentation, including qualification protocols and reports.
- Define and support risk-based qualification and validation strategies.
- Ensure equipment remains in a qualified state through effective management of maintenance, calibration, change control and periodic review activities.
- Act as Subject Matter Expert (SME) for complex qualifications, validation and compliance topics.
- Provide QA oversight for computerized functionalities associated with GxP equipment.
- Review and approve CSV documentation related to equipment software and automated systems.
- Ensure data integrity requirements are appropriately implemented and maintained throughout the equipment lifecycle.
- Assess quality and compliance impacts associated with equipment implementation, modifications and upgrades.
- Review and approve deviations, investigations, CAPAs, change controls and risk assessments related to equipment.
- Support the introduction of new laboratory and manufacturing equipment from a Quality Assurance perspective.
- Support complex and strategic quality initiatives related to equipment qualification, validation and compliance.
- Partner with Engineering, Manufacturing, Maintenance and Validation stakeholders to proactively identify, mitigate and resolve quality and compliance risks related to GxP equipment.
- Review and approve SOPs, work instructions and quality documentation related to equipment qualification, validation, maintenance and lifecycle management to ensure compliance with regulatory requirements and company procedures.
- Review and approve periodic reviews, audit trail assessments and data integrity controls associated with computerized laboratory and manufacturing equipment within the area of responsibility.
- Escalate significant quality and compliance risks related to equipment qualification, validation or computerized equipment to management as appropriate and support the definition of remediation actions.
- Participate in internal audits and regulatory inspections and support inspection readiness activities.
- Drive continuous improvement initiatives related to equipment lifecycle management, validation processes and quality systems.
- Promote quality culture and foster understanding and application of cGMP requirements, quality standards and validation principles across supported functions.
- Promote risk-based, compliant and pragmatic approaches in accordance with GMP requirements and company standards.
Delegate to: QA Engineering Specialist and QA Engineering & CSV Manager
REQUIREMENTS
- Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
- Firsthand experience of min 5 years in an Engineering / CSV position with confirmed experience in a Quality position
- Thorough knowledge in cGMP and international regulatory requirements
- Thorough knowledge in qualification and validation activities (equipment and computerized system)
- Fluent in French and English written and spoken
- Ability to make pragmatic and compliant decisions
- Strong result orientation and committed team member
- Good written and verbal communication skills.
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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