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Quality Systems Coordinator, Cork



Cork, Ireland 

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€0.00 - €0.00

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Job Description:

Quality Systems Coordinator; Pharmaceutical; Cork; Permanent


* Responsible for the controlled documentation process in compliance with cGMPs, US FDA and other applicable regulations and company requirements and assist in its continuous improvement.
* Ensure effective maintenance of the documentation management system and collaborate with department to ensure effective resolution of document system queries or requests
* Ensure Good Documentation Practices are adhered to in line with current Good Manufacturing and distribution Practices (cGMDP)
* Co-ordinate the Change Control request documentation from CMO sites
* Participate in internal and external compliance audits as related to QADC activities
* Maintain the GMDP training system and responsible for ensuring all training records are maintained in compliance with cGMPs, US FDA and other applicable regulations and company requirements.

Knowledge and Skills:

* Knowledge of FDA and HPRA regulations and GMDP practices
* Effective communication, presentation and report writing skills
* Excellent analytical abilities to grasp the key points from detail and report back to the quality team
* Excellent attention to detail
* Proven ability to work as part of a team and be flexible in approach to work
* Excellent organisational and time management skills; with the ability to prioritise effectively
* Evidence of ability to work proactively and with initiative
* Excellent interpersonal skills

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.
Company Info
Morgan McKinley

Phone: +353 (0)21 2300300
Web Site: http://www.morganmckinley.ie
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