Overview
SUMMARY
The role will manage the Quality oversight of the computerized systems validation activities as well as the data integrity program at Incyte large scale biological manufacturing facility at Yverdon-les-Bains, Switzerland.
Responsibilities will include supporting from a QA standpoint the introduction or upgrade of systems used at the manufacturing facility. Specifically, this position will support all qualification and validation activities of computerized and automated systems (e.g. MES, PLC/SCAPA, EMS, LIMS, SAP) of biopharmaceutical drug substance manufacturing according to quality policies, cGMP, EU/US regulations and Swiss regulation.
DUTIES AND RESPONSABILITIES
Manage the day-to-day quality oversight of GxP IT, Computerized System Validation (CSV) and Automated and Computerized systems (SISA) related activities
Act as the main point of contact for all quality compliance key topics regarding GxP IT, CSV, and SISA
Act as the main point of contact for all data integrity related activities/initiatives and own the data integrity related SOPs
Review and approve GxP IT, CSV, and SISA SOPs to ensure compliance with Incyte Policies and regulatory requirements (including 21 CFR part 11 and data integrity requirements)
Ensure compliance of GxP IT, CSV, and SISA activities with cGMPs and approved procedures
Support the Commissioning & Qualification activities
Review and approve the URS and relevant design documentation
Actively support the risk assessment exercises
Review and approve SISA related documentation (SOPs, FAT/SAT protocols and reports, qualification protocols and reports) to ensure compliance with cGMP and applicable regulations
Review and approve data audit trail, system audit trail and periodic review of systems used at the BioPlant
Review and approve deviations and investigations in the area of responsibility. Escalate as appropriate to management major / critical issues
Recommend and approve CAPA plans and ensure timely implementation
Review, assess and approve implementation of changes in the area of responsibility
Ensure alignment with Global QA CSV organization
Perform quality audits for SISA suppliers if needed
Support Inspection readiness activities and represent QA function for GxP IT, CSV, and SISA department related matters in Health Authorities inspections
Foster compliant and right first-time activities
Operate in close proximity with SMEs in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events
Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by BioPlant employees
Partner with internal stakeholders to ensure efficient collaboration
Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable
Performs all responsibilities in accordance with company policies, procedures, applicable regulations, and safety requirements
Stay current with the applicable regulations and promote Quality across the Incyte organization
Contribute positively to a strong culture of business integrity and ethics
Act within compliance and legal requirements as well as within company guidelines
REQUIREMENTS
Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
Firsthand experience of min 10 years in a CSV/QA CSV position with a confirmed experience in a Quality position
Thorough knowledge in cGMP and international regulatory requirements
Thorough knowledge in qualification and validation activities
Experience in dealing with International inspections
Strong analytical and problem-solving skills
Strong result orientation and committed team member
Ability to make pragmatic and compliant decisions
Good verbal and written communication skills with well-structured communication
Compliance focused
Auditor qualification is an asset
Fluent in French and English written and spoken
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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