|Job Title:||Documentation Controller|
|Contact Name:||Laurentina Kennedy|
|Job Published:||4 months ago|
Our client is a highly ambitious young cell therapy company, seeking a strong self-starter experienced in setting up documentation processes.
Store, manage, and maintain company documents, while ensuring the accuracy and quality of them. Process documents for revision and approval, organise documents from conception to distribution and filing, and create systems which can then be used to train staff on document control processes. Set up and implement a centralised documentation system ensuring common systems for issuance, retrieval, review and archival of data. Identify and manage systematic breakdown in documentation systems and carryout preventative and corrective actions (CAPA).
Set Up Guidelines: Assist in the development of the process, review, and approval of all new and/or revised controlled documentation, delivers training to company employees on the correct document practices, process per standard operating procedures (SOP). Oversee Receipt and Storage of Files: Oversee the download and upload of files or emails from and to the company secure SharePoint, assess the accuracy of the documents. Check the files for completeness, record them into the system according to a file index.
Check Documentation Compliance: Coordinate with clients to track and issue documents, check that the documents comply with regulations and work with clients to revise documentation where needed. Periodically review documents and records for completeness and compliance requirements and Company procedures.
SharePoint and Data room: Set up an efficient operational system and maintenance of correct file structure on SharePoint and in Data room to facilitate file retrieval and due diligence,
Organise and Maintain Documents: Scan documents, then organise them to maintain them, adhering to the company’s document lifecycle procedures. Any inactive documents and records are then archived. Control the administration of issuance, retrieval, logging of protocols, use of labels, deviations, investigations etc.
Implement and manage a KPI system including recommendations for systems modification
Review and disseminate regulatory guidelines
File PSF and TMF documents and ensure compliance
Key liaison during audits from documentation perspective
Process Requests for Information: Receive “Requests for Information,” or RFIs, from clients, employees, or regulatory authorities (FDA, EMA, …) and maintain these requests using tracking logs, which are updated as document controller creates new templates accordingly. Co-ordinate and monitor the completion of key documentation to meet regulatory timelines for CTA/IND filings.
Training: Maintain employees training matrix and records. Determine additional training needs on revised documents as appropriate.
Requires a Bachelor’s degree or MSC plus six (6) years’ experience in a quality discipline in drug development and two (2) years in document control
Excellent communication and teamwork skills.
An understanding of ICH guidelines, GXP documentation control governing drug development is strongly preferred.
Computer proficient and be able to demonstrate a high level of accuracy.
Required Competencies – Knowledge, Skills, Abilities
Full appreciation of the drug development cycle and cGMP/documentation requirements
Excellent verbal and written communication skills
For further information on this Documentation Control position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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