Our client is a highly ambitious young pharmaceutical 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 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 ftp files or emails from and to the company secure cloud-storage, 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.
Organize and Maintain Documents: Scan documents, then organize them to maintain them, adhering to the company’s document lifecycle procedures. Any inactive documents and records are then archived.
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 control specialist creates new templates accordingly.
Training: Maintain employees training matrix and records. Determine additional training needs on revised documents as appropriate.
- Requires a Bachelor's degree 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 governing pharmaceutical drug development is strongly preferred.
- Computer proficient and be able to demonstrate a high level of accuracy.
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