Computer System Validation - Senior Quality Assurance Analyst 

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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, Olen, Antwerp, Belgium

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

As a Computer System Validation - Senior Quality Assurance Analyst you will:

Have a passion for Quality, love well-functioning systems and you are eager to gain in-depth knowledge of the quality & compliance requirements in this field? Then this position is waiting for you!

We as QA CSV group belong to the Quality organization of Johnson & Johnson Innovative Medicine Supply Chain (IMSC) and are responsible to ensure the quality and compliance of different systems on the J&J Belgian Campus (including commercial and clinical activities in Beerse, Olen and Geel).

To strengthen this team, we are looking for a Quality Assurance Computer System Validation Engineer (M/F/X), located mainly in Beerse Belgium, with focus on IMSC Beerse/Olen systems.

The function will allow up to 2 days per week work at home.

Key responsibilities:


* Assure that all Computer System Validation related regulatory requirements are fulfilled during the complete life cycle of computerized systems (concept, project, operational and retirement phase).


* Act as Process Owner for Computer System Validation management.


* Review and approve CSV documents such as SOPs, user requirements, risks analysis’s, validation plans, test scripts, changes, deviations etc) in order to maintain compliance to regulations, guidelines, J&J policies and standards.


* Maintain a current knowledge of international laws, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies.

Implement this knowledge to maintain and improve CSV at J&J IMSC.


* Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.


* Be the spokesperson for CSV related matters during audits and inspections.


* Perform and foll...