Document Controller

Our Client is a world leader in contract research servicing the Pharmaceutical, Medical Device and Veterinary Industries. With more than 8,000 employees world-wide they operate in 50 countries.

The Irish facility based in Co. Mayo is currently seeking an experienced Document Controller to manage the document control and archive function and has two people reporting to this role.

The main duties of this role are as follows:

• Manage the Standard Operating Procedures (SOPs) Function for all Departments.

1. Organise production & identification of authenticated copies for distribution
2. Ensure timely distribution to all relevant personnel
3. Ensure timely withdrawal of defunct SOPs and archive
4. Maintain master SOP file, master indexes of SOP numbers and distribution lists.
5. Write, Review and update Document Control related SOPs.

• Manage the Archive function as follows:

1. Monitor the condition/integrity of the Archives on a weekly/monthly basis.
2. Acceptance of materials into the archive.
3. Checking indexes of materials presented for archiving.
4. Maintenance of Lodgments/Withdrawals file and Occurrence files.
5. Monitoring of withdrawals from the Archives.

• Liaise with clients in relation to any query they may have concerning their stored documentation including the return/destruction of data on behalf of the client.
• Liaise with all Departments on a daily basis.
• Management of staff to include training, appraisals etc.
• Ensure the process of stored documentation and SOP function remains compliant with GMP & GLP regulations.
• Participate in client and regulatory audits as required.

The successful candidate must have:

Excellent Organisational and Administrative skills.

Good Attention to Detail.

Experience of working in a GMP or GLP environment.

Excellent supervisory/management skills

Hold a degree in a relevant Science/Management discipline