Job description Posted 08 October 2019

Key Responsibilities:

You will work with team of experts in compliance, validation of computerised systems and analytical instrumentation to support the evaluation of computerised systems in a GMP environment.

  • Co llaborate with the Systems’ Compliance team to support data integrity evaluations & gap analysis in a GMP environment.
  • Contribute to validation documentation supporting the implementation of the standard evaluation templates and feedback on the suitability of the templates.
  • Analyse the systems with the aid of existing validation documentation.
  • Provide metrics to monitor progress of validation activities.
  • Speak to system leads and or end users to understand bugs when tickets are raised.
  • Work with developers to informally test fixes for bugs in systems.
  • Develop validation test cases to comprehensively test system processes and bug fixes for specific analytical techniques in the system.
  • Perform validation using existing validation test cases for specific analytical techniques in a system.
  • Record the results of the validation in the validation test record.
  • Summarise the validation in a validation test summary
  • Raise and manage validation defects in ALM (application lifecycle management) app.

Applicant Skills Sought – not prerequisites as full training will be given

  • Bachelors degree or higher in Science related subject
  • Experience in using a range of computerised analytical systems for example Labware, Empower, Chemstation (UV-Vis), Bruker Opus, Waters etc.
  • Exposure to computer system validation and change control documentation in a regulated environment and the ability to understand and apply the information contained therein.
  • Working knowledge of Data Integrity and GMP practices concerning data in the pharmaceutical or similarly regulated industry.
  • A mindset and desire to use modern technology to improve the efficiency and effectiveness of the processes used to validate computer systems and analytical equipment.
  • Comprehensive training will be provided for specific tasks

Career Development Opportunity

PDS Systems Compliance is creating a team to remediate and validate a range of computerised systems and ensure their compliance with the latest MHRA guidance on Data Integrity. To assist in this process, standard questionnaire style templates have been executed and relevant gaps have been identified. These will be used by the successful applicants to mitigate the gaps identified in each system.

Quality and compliance has been built into the templates, however a degree of critical thinking and good attention to detail will be necessary for successful candidates. The team is small but multi-disciplinary and you will need to work well with scientists, managers and other technical colleagues outside your field of expertise; excellent communication skills are required.

Training Provided

The employee will work closely with and learn from laboratory automation, analytical chemists, quality experts and validation specialists to understand what is being validated. They will use modern documentation production and storage techniques to document the validation and compliance of our systems.

Additional information about the process

Who Are We - GSK?

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc , although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.Our values and expectations are at the heart of everything we do and form an important part of our culture:

Our values are Patient focus, Transparency, Respect, Integrity