Quality Assurance CSV Consultant

Quality Assurance CSV Consultant

Location: Geel, Belgium

Duration: 3 months

Hours: Full time, hybrid 

Imagine your next project as a Quality Assurance CSV Consultant, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

• Assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for computerized systems.

• Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis’s, Validation Plans, tests, etc…) in order to maintain compliance to regulations, guidelines, J&J and Janssen policies and standards.

• Be part of IT/engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.

• Address and follow-up of deviations occurred during execution of CSV activities.

• Evaluate the incidents related to CS and propose corrective/preventive actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if necessary.

• Provide periodic reports on quality system compliance (metrics).

• Prepare for system audits and inspections.

• Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,…), MAP, etc.

• Maintain a current knowledge of international regulations, guidelines and new evolutions related to CSV. Implement this knowledge to maintain and improve Computerized Systems Validation.

how to succeed

• Must be fluent in Dutch and English

• Knowledge of cGMP’s: 21CFR11, 21CFR210, 21CFR211, Directives 75/319/EEC and 2003/94/EC Volume 4 and annex 11 and related GMP Guidelines and Preambles.

• Knowledge of GAMP’s: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System).

• Knowledge of SW development and testing processes.

• Knowledge of Quality auditing

• Knowledge of Software quality metrics

• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.

• Ability to multi-task and work on a variety of projects at one time.

• Ability to work independently and work in cross-functional team environment.

• Good communication skills.

• Good project management skills.

• Good problem solving skills

SYSTEM KNOWLEDGE

• Process control and IT systems used within pharmaceutical and chemical manufacturing: PLCs, MES, LIMS, warehouse management systems, monitoring systems…

• Deviation and Change Management Systems (f.e. COMET, IRIS)

• Microsoft OS, networks, virus protection

• Test Tools (f.e. qTest, Kneat)

details

This role offers a very competitive hourly rate. 

This contract will run for a 3 month duration initially for project needs.

Hybrid (3 days on-site)

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.