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.
He/she will ensure a strong collaboration with other Bioplant functions and will promote compliance and continuous improvement while supporting the timely supply of products.
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 reportsm 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 decision
• 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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