Document Controller

PE Global; Dún Laoghaire-Rathdown; On-site; EUR 42,000 - 56,000; Full time

Job summary

PE Global are recruiting a Document Controller for a biopharmaceutical client in Dun Laoghaire, Dublin. This is an initial 12-month contract role and is fully onsite.

Responsibilities include archiving GMP records, coordinating retrieval, supporting audits, and maintaining electronic record management systems across the site. Strong experience with Smartsheet, CDOCS, SharePoint and Microsoft 365 is required.

Qualifications

• 3+ years in document control or readiness coordination within GMP manufacturing or large-scale projects.
• Proficiency in Smartsheet, CDOCS, SharePoint, and Microsoft 365 tools.

Responsibilities

• Responsible for the archival of GMP records in compliance with record retention schedule.
• Coordinates record retrieval from in-house and external storage providers as required by internal customers.
• Provides archive support during audits and inspections to ensure rapid retrieval of records from internal and external archives as requested by the auditors/inspectors and internal customers.
• Performs record destruction at the end of the retention period for both Amgen and third-party business partners as necessary.
• Understands record requirements and ensures effective resolution of electronic record management system queries or requests.
• Provides support and training to staff on the site electronic record management system.
• Issues, reviews, reconciles and archives paper logbooks in accordance with Good Documentation Practices.
• Prepares documents for offsite storage and coordinates transport of records off-site.
• Identifies improvements to archiving procedures and implements those identified to improve efficiency and streamline the record archival and retrieval process.
• Gathers meaningful metrics for the archival process and critically evaluates the data gathered to be used to drive archive improvement measures and efficiencies.
• Communicates archive deliverables clearly with management and stakeholders on a regular basis.
• Works with all departments to ensure that records are archived in a regular manner and develops a schedule
• Maintains the electronic table of contents for all QA procedures and methods.
• Provides site-wide support on the reconciliation of controlled forms.
• Prepares document listing for audits and inspections.
• Provides support to the Quality Systems team in the generation of team metrics.
• Supports the Quality Systems team deliverable as required during audits and inspections.
• Undertake other duties that may be assigned by manager

Skills

Document control

GMP knowledge

Quality systems

Tools

Smartsheet

CDOCS

SharePoint

Microsoft 365

Job description

PE Global are recruiting for a Document Controller for our biopharmaceutical client based in Dun Laoghaire, Dublin. This is an initial 12-month contract role. *Fully Onsite*

Job Responsibilities

• Responsible for the archival of GMP records in compliance with record retention schedule.
• Co-ordinates record retrieval from in-house and external storage provider as required by internal customers.
• Provides archive support during audits and inspections to ensure rapid retrieval of records from internal and external archives as requested by the auditors/inspectors and internal customers.
• Performs record destruction at the end of the retention period for both Amgen and third-party business partners as necessary.
• Understands record requirements and ensures effective resolution of electronic record management system queries or requests.
• Provides support and training to staff on the site electronic record management system.
• Issues, reviews, reconciles and archives paper logbooks in accordance with Good Documentation Practices.
• Prepares documents for offsite storage and co-ordinates transport of records off-site.
• Identifies improvements to archiving procedures and implements those identified to improve efficiency and streamline the record archival and retrieval process.
• Gathers meaningful metrics for the archival process and critically evaluates the data gathered to be used to drive archive improvement measures and efficiencies.
• Communicates archive deliverables clearly with management and stakeholders on a regular basis.
• Works with all departments to ensure that records are archived in a regular manner and develops a schedule
• Maintains the electronic table of contents for all QA procedures and methods.
• Provides site-wide support on the reconciliation of controlled forms.
• Prepares document listing for audits and inspections.
• Provides support to the Quality Systems team in the generation of team metrics.
• Supports the Quality Systems team deliverable as required during audits and inspections.
• Undertake other duties that may be assigned by manager

Educations & Experience

• 3+ years in document control or readiness coordination within GMP manufacturing or large-scale projects.
• Proficiency in Smartsheet, CDOCS, SharePoint, and Microsoft 365 tools.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****