LSC have a great contract opportunity for a Document Controller to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
Description
- Responsible for the archival of GMP records in compliance with Amgen'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 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Amy Smyth on 021 4777329 if you have anymore questions about this role!
