Documentation Specialist

11 Aug 2017
01 Sep 2017
Justin Pankinas
Job Type
Our client is a multinational pharmaceutical giant looking to forever expand their professional team and dominate the industry moving forward. Their most recent additional requirement is for a Documentation Specialist to carry out the tasks described below.

Job purpose:
Responsible for supporting the Quality Department in the management of the site GMP documentation and in supporting the Quality functions in various administrative duties. Ensure that objectives are effectively achieved, consistent with the Client's requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities are but not limited to:
*Responsible for the control, operation and maintenance of the site Central Documentation Control system.
*Be a document system expert; this will include document generation, review, approval and document system work flow expedition e.g. SOP's, SWI's, Policies, Monographs, MARs, write, deliver and review necessary documentation in line with the standard approval process.
*Support site activities through documentation generation, filing, tracking, auditing and maintenance of associated databases including MIDAS & Trackwise.
*Control and issuance of logbooks.
*Support department/site to be audit ready. This will include the coordination of deviation review meetings, conducting site driven audits

*Relevant 3rd level education or extensive relevant experience
*Experience and or a particular skill set in their area of expertise that adds value to the business, preferably in a manufacturing GMP environment.
*Proficiency in Microsoft Office and job related computer applications required
*Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
*Report, standards, policy writing skills required
*Understanding of Lean Six Sigma Methodology preferred
*Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team orientated manner
*Effective time management and multi-tasking skills

For more information contact

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