Doc Controller

PE Global (UK); Dublin; On-site; EUR 42,000 - 56,000; Full time

Job summary

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

You will manage GMP records, coordinate retrieval, support audits, maintain electronic and paper archives, and drive improvements in archival processes while collaborating with QA and other departments.

Qualifications

• Bachelor’s degree in Science or Engineering.
• 3+ years in document control within GMP manufacturing or large-scale projects.
• Proficiency in Smartsheet, CDOCS, SharePoint, and Microsoft 365 tools.

Responsibilities

• Archive GMP records in compliance with the retention schedule.
• Coordinate retrieval of records from in-house or external storage.
• Provide archive support during audits and inspections for rapid retrieval.
• Destruction of records at end of retention period as required.
• Maintain electronic record management system queries and requests.
• Train staff on the site electronic record management system.
• Manage paper logbooks per Good Documentation Practices and archive them.
• Prepare documents for offsite storage and coordinate transport.
• Identify improvements to archiving procedures and implement them.
• Gather metrics and use data to drive archive improvements.
• Communicate archive deliverables with management and stakeholders.
• Work with all departments to ensure regular archiving and scheduling.
• Maintain the electronic table of contents for QA procedures.
• Support reconciliation of controlled forms and audits.
• Prepare document listings for audits and inspections.
• Support QA Systems team metrics and deliverables during audits.
• Undertake other duties as assigned.

Skills

Smartsheet

CDOCS

SharePoint

Microsoft 365

Education

Bachelor's degree in Science/Engineering

Job description

The Role

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

• Bachelor’s degree in Science/ Engineering
• 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