వి
Document Control Specialist
Galway, County Galway, Ireland · ఒప్పందం
దరఖాస్తు చేసుకునే వారిలో మొదటి వ్యక్తిగా ఉండండి
- అనుభవం
- 1–4 సంవత్సరాలు
- జీతం
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- ఖాళీలు
- 1
- పోస్ట్ చేయబడింది
- 2 గంటల క్రితం
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- కార్యాలయంలో
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- దరఖాస్తు చేసుకోవాలి
మీరు ఎక్కడ పని చేస్తారు
ఉద్యోగ వివరణ
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.