Computer System Validation Consultant

2 weeks ago


Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time
Roles & Responsibilities

We are seeking an experienced Computer System Validation Consultant to help drive our solution-based business model and take our designs to the next level. Our consultants have the chance to work hands-on with several business divisions to design, develop, test industry-leading solutions for our clients—both nationally and internationally. Our ideal candidate is a creative thinker who shares our passion for making people’s lives easier.


Responsibilities:

  • Create and refine validation protocols for GxP critical reports, focusing on Computerized Equipment Validation within the QC lab.
  • Configure static Master Data for validated/GMP-compliant LabWare LIMS (version 6), specifically emphasizing Computerized Equipment.
  • Actively participate in executing, reviewing, and approving validation protocols for Computerized Equipment.
  • Generate Change requests and IT tickets tailored for report validation of Computerized Equipment.
  • Validate business intelligence reports, showcasing expertise in necessary tests for qualification.
  • Review and draft SOPs, specifically for Computer System Validation Projects, with a focus on Computerized Equipment.
  • Develop documentation for Computer System Validation projects, including URS, FRS, FRA, HLCCD, etc.
  • Address and resolve issues during Computerized Equipment validation, including deviations and change controls.
  • Ensure compliance of computerized systems, especially LabWare LIMS and other Computerized Equipment, with relevant regulations.
  • Draft templates for High-Level Risk Assessments, User Requirements Specification, Validation Plans, and Validation Summary Reports, emphasizing Computerized Equipment Validation.
  • Act as a liaison between Quality Assurance and the project team, ensuring strict compliance with regulations for GxP software and Computerized Equipment.
  • Manage planning and execution of Computerized Equipment Validation projects within established timelines and budgets.
  • Coordinate effectively with teams, clients, and stakeholders, specifically for Computerized Equipment Validation.
  • Oversee day-to-day operations of Computerized Equipment Validation projects.
  • Ensure completeness, review, approval, and proper storage of project documents related to Computerized Equipment Validation.
  • Keep the Computerized Equipment Validation team well-informed of project changes.
  • Experience with Kneat and validation of around 15 computerized systems (LCE), excluding Electrical Equipment (EE).


Required Qualifications:

  • Bachelor’s degree in business/technical field or equivalent education/experience.
  • 3 to 5 years of experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment, involving IOQ/PQ authoring and execution, traceability matrices, and risk assessments.
  • Prior experience with Takeda and familiarity with Emerson Delta V software is a plus.
  • Strong technical skills in configuring various Laboratory systems, including Standalone instruments like Mass Spec, IC, Matersizer, UV, FTIR, DSC, etc.
  • Understanding and ability to configure TCP/IP network connectivity between systems.
  • Excellent knowledge of Desktop Operating systems, including Windows 2000, Windows 7, and Windows 10, covering permissions, user configuration, and peripheral device connections.
  • Proficient in drive mapping, logon scripts, and analyzing system logs.
  • Good understanding of Active Directory, Domain permissions, and LDAP.
  • Advanced understanding of data system security for safeguarding electronic assets, intellectual property, and privacy.
  • Experience in developing and implementing complex data exchange processes between information systems.
  • Proficient in creating/developing moderately to complex functional requirements mapping to an Information System based on user needs.
  • Ability to independently identify compliance risks and escalate when necessary.
  • Self-starter with strong team communication skills.
  • Proven ability to lead a team.

Tell employers what skills you have

FTIR
GxP
Computer Systems Validation
Windows 10
Quality Assurance
GMP
Windows 7
Electrical
Traceability
Computer System Validation
LIMS
UV
Laboratory
Windows 2000

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