Data Integrity Specialist

Data Integrity Specialist

Location: Schaffhausen - Hochstrasse

Duration: 12 months

Hours: 40 hours per week, hybrid

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, treatments are smarter and less invasive, and solutions are personal.

The Cilag AG is an international manufacturing company of the Johnson & Johnson Group's Janssen pharmaceutical division and manufactures pharmaceutical products and medical devices as well as active pharmaceutical ingredients (APIs) for global markets at its production site in Schaffhausen. With its innovative products, processes, and technologies, Cilag AG is one of the leading pharmaceutical companies in Switzerland and at the same time a strategic location for product launches.

Within the Quality Control (QC) department, we are looking for a dedicated personality as a Data Integrity Specialist.

roles and responsibilities

• Drafting and supporting revision of data governance related work instructions / SOPs

• Data integrity / data governance related instrument assessments and remediation

• Planning and coordinating qualification activities for laboratory equipment in compliance with current GMP and regulatory requirements

• Preparation and execution of change control records related to equipment lifecycle management

• Installation, configuration, testing and maintenance of application software and system management tools

• Definition of requirements for new software applications, analysis of process and data flow and creation of corresponding flowcharts

• Maintenance of security, backup, and recovery strategies for databases and other data systems

• Support with the investigation into deviations caused by non-conforming software and implement solutions (CAPA)

• Liaise with vendors and other IT personnel for problem resolution (e.g., technical support for manufacturer qualifications, maintenance & calibration, troubleshooting and investigations)

how to succeed

You enjoy working in a team and have strong teamwork and communication skills. You approach challenges in a solution-oriented and systematic manner, can solve complex and multi-layered tasks and set the right priorities. In addition to your assertiveness, you are willing to take on responsibility and enjoy making a difference and advancing projects.

In addition, you have the following:

Education:

• MSc / BSc degree in Natural Sciences, Computer Science, Engineering, or alternatively comparable training with several years of professional experience

Experience and Skills:

Required:

• Previous Training and Experience in Data Integrity / Governance in GMP environment (Part 11 / Annex 11)

• Qualification Experience (GMP, preferable for laboratory equipment / CSV)

• Excellent communication skills

• Experience in project management

• Very good knowledge of Microsoft Office programs (Outlook, Word, Excel, PowerPoint)

• Fluent in English. German is a preference

Preferred: 

• Hands on experience with instrument or software qualification and documentation (e.g., CSV, qualification of production plants, laboratory equipment)

• IT experience / affinity

• Experience with databases, networks (LAN, WAN) and patch management

• Excellent analytical skills and problem-solving attitude

• Experience with virtualization (e.g., VMware, Virtual Box)

• Experience with TrackWise, SAP and TruVault is an advantage

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 month duration and has a good chance of extension. 

you are welcome here

Johnson & Johnson 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

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

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”.