Computer System Validation Consultant - Singapore - PHARMENG TECHNOLOGY PTE. LTD.

PHARMENG TECHNOLOGY PTE. LTD.

Verified Company

Singapore

3 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

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/GMPcompliant 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 daytoday 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 wellinformed 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.
Selfstarter with strong team communication skills.
Proven ability to lead a team.