Lab Systems Specialist

I8477

Lab Systems Specialist required for Dublin based Pharmaceutical client

Category:
IT
Location:
Leinster
Years of Experience Req.:
3-5 Years+
Date Posted:
13/05/2021
Days Remaining:
27
Employment Type:
Contract
Education Level Req.:
See Description

Lab Systems Specialist 

DPS have a requirement for a Lab Systems Specialist with a Dublin based Pharmaceutical client. 

Role requirements: 

  • Perform system administrator role on QC computerised systems including systems security access, audit trail, periodic audit trail reviews and routine administrative tasks.
  • Troubleshooting hardware and software issues on QC systems with IT department and system providers as required.
  • Generation of new functionality within QC computerised systems.
  • Responsible for ensuring that the administration of GMP computerised systems in your remit is carried out in a manner which ensures the integrity of the data created, modified or maintained on the systems.
  • Completion of necessary software systems documentation reviews including periodic reviews, ERES assessments, data integrity reviews and SOP updates.
  • Participation in project planning and implementation of software and hardware systems within the QC laboratory.
  • Responsible for the initiation and implementation of change controls within QS, as required.
  • Liaise with appropriate Quality department members in developing or changing aspects of the system and ensuring it meets departmental requirements.
  • Technical lead on Instrument Qualification projects.
  • Prepare and execute instrument protocols
  • Train end users/QC Chemists on QC computerised/GMP systems
  • Provide end user support on QC computerised systems
  • Assist the QC laboratory with any QC computerised systems support and IT related issues.
  • Support site projects as required.
  • Investigate any non-conformance, equipment failures, accident or near miss.
  • Ensure relevant KPIs and quality objectives are achieved
  • Maintain and update QC/QS documentation in accordance with regulations.
  • Work with management and staff to foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
  • Control of changes to QC laboratory instruments
  • Ensure compliance with relevant regulations and standards associated with cGMP, ISO 14001, EMAS, Health & Safety Legislation, Environmental Legislation, and also all site standards, policies, and procedures.
  • Support SAP projects and QM master data maintenance.
  • Support Continuous Improvement process onsite.
  • Ensuring GMP and regulatory requirements are maintained within the QC environment.
  • Other issues as directed by Supervisor.

Requirements

  • Degree in Science
  • Minimum 5 years experience in a similar environment
  • Experience in CSV and laboratory systems administration
  • A thorough understanding of the validation lifecycle
  • Ability to work on own initiative and as part of a project team
  • Troubleshooting and problem solving skills
  • Experience in the participation in projects is vital to this role
  • Good knowledge of cGMPs, ICH and GAMP requirements and other industry regulations and standards

 

DPS is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

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