- 经验
- 1-4岁
- 薪水
- —
- 职位空缺
- 1
- 发布
- 6小时前
- 工作模式
- 在办公室
- 恢复
- 需要申请
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职位描述
Overview
We are aiding a leading pharmaceutical facility in a significant digital transformation, particularly through the deployment of a new global Laboratory Information Management System (LIMS). This role centers on managing document control, change management, and SOP conversions to ensure precise migration of all lab documentation into a digitally controlled system, supporting the shift to a paper-free environment.
Key Responsibilities
- Oversee change control workflows within TrackWise, facilitating LIMS implementation tasks.
- Handle updates, amendments, and corrections to SOPs aligned with GMP compliance.
- Upload and maintain documents on Documentum, ensuring proper management.
- Coordinate review and approval processes among QA, QC, and project teams.
- Assist in converting paper-based procedures into organized digital formats.
- Ensure documentation meets SDLC, validation, and regulatory compliance standards.
- Maintain readiness for audits through accurate document control and version tracking.
- Support validation efforts with precise documentation of protocols, reports, and training content.
Requirements
- Between 1 to 4 years of experience in pharmaceutical or GMP-regulated settings.
- Demonstrated experience in managing change control processes, preferably with TrackWise.
- Familiarity with document management platforms, Documentum experience is advantageous.
- Solid understanding of SOP management, document lifecycle, and GxP documentation standards.
- Meticulous attention to detail with an organized and systematic work approach.
- Strong written communication skills, especially for producing technical documentation.
Preferred Qualifications
- Experience with LIMS systems or laboratory workflow environments.
- Background in supporting validation and SDLC documentation processes.
- Knowledge of QC laboratory procedures or analytical workflows.
Contract Information
- Duration: 12-month fixed contract.
- Work Location: Onsite, five days per week in the Galway area.
- Start Date: Immediate availability preferred.