Document Controller

Summary:
A Document Controller is required for a biopharmaceutical company in South Dublin.

Responsibilities:

• Responsible for the archival of GMP records in compliance with the company’s 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 the company 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.

Qualifications & Experience:

• Third level qualification e.g. B.Sc . in science/pharmacy.
• 1 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
• Document Management experience.
• Excellent MS Word and Excel skills.