Job Summary (Primary function)
Supports the Quality Assurance activities associated with the start-up of a new green-field large scale API bio-manufacturing facility.
Responsibilities include supporting the qualification and validation during the procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment used for manufacturing. Specifically this position will support all qualification activities for Dispensing, Media Preparation, Buffer Preparation and Washing Area as main scope as well as Upstream, Downstream manufacturing and Support departments as related scopes according to Quality policies, cGMP, Swiss, EU and US FDA Regulations.
During the qualification period, this function also participates to the implementation of the bioplant operations and associated controlled documents.
Once the new site will be qualified, this position will support locally the site manufacturing operations including regular presence in the manufacturing and support areas in order to foster compliant and right first time operations. Specific duties include the review and approval of non-executed and executed manufacturing batch records and analytical records, quality-related operations for unexpected events, CAPAs, change controls, documentation, trainings, periodic reviews (not exhaustive).
Essential Functions of the Job (Key responsibilities)
During the project phase,
• Act as the main point of contact for all quality compliance key topics regarding Process and the related equipment
• Review and approve the URS and relevant documentation and support actively the risk assessment exercises (FMECA)
• Support the Commissioning & Qualification activities during FAT at suppliers and on site
• Support the creation of procedures, protocols and reports for qualification / validation
• Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams
• Act within compliance and legal requirements as well as within company guidelines
• Support the implementation of the bioplant manufacturing operations (GMP site readiness) as well as the associated documentation.
• Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
• At all times work in a right first time and site readiness approaches for regulatory inspections (Swissmedic and International)
• Contribute positively to a strong culture of business integrity and ethics
• Lead or contribute to suppliers auditing
• Review and approve non-executed and executed manufacturing batch records
• In your QA function, manage in a proactive and integrated way change controls, documentation, trainings, periodic reviews, unexpected events and CAPAs
• Support the products change-over for manufacturing campaigns
• Lead or contribute to the elaboration of risk assessments
• Contribute and support the elaboration of periodic reviews
• Operate in close proximity with manufacturing in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events
• Contribute to the auditing process (as auditor for self-inspections and suppliers)
• Support the Heath Authorities inspections through your personal expertise field as well as through the QA function
• Support quality operations related to support functions including incoming goods management.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
• Advanced degree preferred
• Minimum of 5 years in a Quality Assurance role in a biopharmaceutical manufacturing environment
• Expertise in microbiology is a plus
• Speak, read and write in English and French
• Thorough knowledge of biotechnology processes
• Demonstrated proficiency in good practice requirements cGMP as well as biopharmaceutical industry regulations and standards related to qualification and validation
• Proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems
• Experience in Health Authorities inspections
• Ability to make pragmatic and compliant decisions
• Strong result orientation and committed team member
• Flexibility and ability to travel
• Excellent written and verbal communication skills.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
During the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.
Please contact firstname.lastname@example.org if you have any questions or concerns or would like to exercise your rights.
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.