Documentation Controller - 12 Month Contract
AI Summary
Manages site documentation systems, ensuring compliance with quality, regulatory, and operational requirements by controlling, distributing, maintaining, and archiving critical documents.
About this role
Documentation Controller - 12 Month Contract
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
We are seeking a highly organised and detail-oriented Documentation Controller to manage and maintain site documentation systems, ensuring compliance with quality, regulatory, and operational requirements. The successful candidate will be responsible for the control, distribution, maintenance, and archiving of critical documentation while supporting continuous improvement and inspection readiness activities across the site.
Key Responsibilities
- Receive and manage documents from the Global Documentation Management System.
- Generate, update, maintain, and issue internal controlled documentation.
- Manage and control changes to documented procedures.
- Conduct documentation audits and ensure current approved document revisions are available across the site.
- Issue and manage batch record documentation.
- Control the storage and archiving of completed batch records.
- Maintain validation and engineering/process validation documentation.
- Process and manage document change requests.
- Support and comply with all EHS&E standards, procedures, and policies.
- Provide support and administration for the Document Centre Helpdesk.
- Support regulatory inspection and PAI (Pre-Approval Inspection) readiness activities.
- Compile, analyse, and report departmental metrics and KPI data.
- Collaborate with cross-functional teams to ensure document control processes meet compliance requirements.
- Drive continuous improvement initiatives related to documentation management.
Qualifications
Essential
- Qualification in Business Administration, Office Administration, or a related discipline.
- Strong IT proficiency, including document management systems and Microsoft Office applications.
- Excellent organisational skills with strong attention to detail.
- Strong written and verbal communication skills.
Desirable
- Previous experience in a document control, quality, compliance, or administrative role within a regulated environment.
- Experience managing technical or quality documentation.
- Experience working within pharmaceutical, medical device, biotechnology, or manufacturing industries.
Additional Information
- Working Hours: 8am-4:30pm
- Contract: 12 months
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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