Morgan McKinley·1 day ago
1 day agoBe an early applicant
Document Controller
Sign up free to see how well your resume matches this role.
What you'll do
- Document Life Cycle Management: Coordinate the creation, review, approval, revision, and retirement of site controlled documents (SOPs, Work Instructions, Forms, Batch Execution Records, Specifications) using Electronic Document Management Systems (EDMS).
- Quality & Compliance Oversight: Ensure all document workflows strictly comply with site Quality Management System (QMS), Annex 11 / CFR Part 11 Data Integrity, and ALCOA+ principles.
- Archiving & Retrieval: Maintain physical and electronic document archives. Manage secure record retention schedules and enable fast retrieval of records during internal, customer, and regulatory audits (e.g., HPRA, FDA).
- Training Administration Support: Act as local administrator for the Quality Management and Learning/Training platforms (e.g., electronic LMS), tracking document-driven training workflows prior to effective date implementation.
- Continuous Improvement: Track document change controls, identify workflow bottlenecks, and issue monthly KPI reports on review timelines and document aging.
What they're looking for
- Diploma or Bachelor's degree in Science, Engineering, Business, or a related discipline.
- 2+ years of documentation control or QA administration experience within a regulated Pharmaceutical or Medical Device environment.
- Hands-on experience with EDMS software (e.g., Veeva, TrackWise, Documentum, MasterControl) and Learning Management Systems (LMS).
- Sound understanding of cGMP principles, GDP (Good Documentation Practice), and data integrity guidelines.
- Ability to work full-time (5 days per week) onsite
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
The QA Document Controller will manage the day-to-day administration, distribution, archiving, and maintenance of Good Manufacturing Practice (GMP) documentation at the clients site. This role ensures all Site Standard Operating Procedures (SOPs), batch records, technical protocols, and training records adhere to strict EU/FDA GxP regulatory standards.
Key Responsibilities
- Document Life Cycle Management: Coordinate the creation, review, approval, revision, and retirement of site controlled documents (SOPs, Work Instructions, Forms, Batch Execution Records, Specifications) using Electronic Document Management Systems (EDMS).
- Quality & Compliance Oversight: Ensure all document workflows strictly comply with site Quality Management System (QMS), Annex 11 / CFR Part 11 Data Integrity, and ALCOA+ principles.
- Archiving & Retrieval: Maintain physical and electronic document archives. Manage secure record retention schedules and enable fast retrieval of records during internal, customer, and regulatory audits (e.g., HPRA, FDA).
- Training Administration Support: Act as local administrator for the Quality Management and Learning/Training platforms (e.g., electronic LMS), tracking document-driven training workflows prior to effective date implementation.
- Continuous Improvement: Track document change controls, identify workflow bottlenecks, and issue monthly KPI reports on review timelines and document aging.
Key Requirements
- Education: Diploma or Bachelor's degree in Science, Engineering, Business, or a related discipline.
- Experience: 2+ years of documentation control or QA administration experience within a regulated Pharmaceutical or Medical Device environment.
- Technical Skills: Hands-on experience with EDMS software (e.g., Veeva, TrackWise, Documentum, MasterControl) and Learning Management Systems (LMS).
- Regulatory Knowledge: Sound understanding of cGMP principles, GDP (Good Documentation Practice), and data integrity guidelines.
- Location & Work Schedule: Ability to work full-time (5 days per week) onsite
Company
Morgan McKinley
Galway, Ireland
Company facts come from this company's own listings. We only show what the postings themselves carry.