Senior Qualification Specialist
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Job Location:
Schaffhausen - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality ControlJob Category:
ProfessionalAll Job Posting Locations:
Schaffhausen SwitzerlandJob Description:
At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at.
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit
Senior Qualification Specialist QC Lab Services (Data Integrity / CSV) 80100% Location: Schaffhausen Switzerland Flexible start date
About the role:
At Johnson & Johnson Innovative Medicine we put health at the heart of everything we do. At our Schaffhausen site we produce pharmaceutical products medical devices and active pharmaceutical ingredients (APIs) for global markets.
Johnson & Johnson Innovative Medicine is seeking a Senior Qualification Specialist to lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories. You will drive lifecycle management of analytical instruments (e.g. HPLC GC UV/VIS) and nonanalytical utilities (e.g. fridges freezers centrifuges autoclaves LAFs) ensuring data integrity and regulatory compliance across systems with and without software in scope.
What youll do:
Instrument Qualification
Plan coordinate and execute equipment qualification and requalification (IQ/OQ/PQ) in line with GMP and site standards
Author and review lifecycle documentation (e.g. URS risk assessments traceability protocols test scripts reports)
Oversee vendor/manufacturer qualifications and integrate supplier documentation into site deliverables
Perform/coordinate installation configuration and testing
Drive troubleshooting and remediation
Computer System Validation & Data Integrity
Execute CSV for analytical software and computerized systems per GAMP 5 21 CFR Part 11 and EU GMP Annex 11
Define and verify requirements functional designs and data/process flows
Establish and assess controls for user management audit trails esignatures backup/restore disaster recovery and corresponding periodic review
Manage data migration/archiving for legacy systems
Procedures Governance & Continuous Improvement
Author and revise WIs/SOPs related to equipment lifecycle CSV and data integrity
Plan and steer (re)qualification campaigns involving multiple departments (QC QA IT Engineering)
Drive standardization and simplification across labs
Investigate and close DI/CSV deviations with effective CAPAs
Leadership Training & Stakeholder Management
Guide and supervise crossfunctional project teams and coordinate timelines and resources
Train and mentor colleagues on CSV Annex 11/Part 11 data integrity and qualification best practices
Collaborate with internal partners and external vendors
Support internal/external audits and health authority inspections
What youll bring:
Education
MSc or PhD in Natural Sciences Engineering Computer Science or related field
Alternatively a Bachelors degree with substantial relevant GMP experience
Required experience & skills
Proven experience qualifying laboratory equipment in a GMP environmentboth with and without software applications in scope
Handson CSV experience for laboratory/software systems in line with GAMP 5 21 CFR Part 11 and EU GMP Annex 11
Strong documentation skills across the validation lifecycle (URS risk assessments IQ/OQ/PQ testing traceability reports)
Practical understanding of data integrity controls (e.g. audit trail review backup/restore testing)
Excellent crossfunctional coordination project planning and problemsolving skills
Fluent English; German at B1 or higher desirable
Nice to have
Experience with QC quality systems and tools (e.g. TrackWise for deviations/CAPA SAP electronic document management such as TruVault)
Familiarity with databases virtualization (e.g. VMware) networked lab systems and Windows domain environments
Exposure to lab automation and integration across multiple analytical platforms
What we offer
A highimpact role shaping laboratory reliability compliance and automation within a global healthcare leader
An inclusive collaborative environment with strong support for worklife balance
A wellconnected location in Schaffhausen and opportunities for ongoing development
Required Skills:
Preferred Skills:
Analytical Reasoning Business Behavior Compliance Management Controls Compliance Cross-Functional Collaboration Innovation ISO 9001 Persistence and Tenacity Problem Solving Process Oriented Quality Auditing Quality Control (QC) Quality Standards Quality Systems Documentation Report Writing Technologically SavvyRequired Experience:
Senior IC
Key Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
