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QUALITY AUDITOR (PHARMACEUTICAL)

 

Job Reference Number

14219756

Client ID:

RI/77716CON2210

Posted On:

Nov 11 2009

Location:

DUBLIN NORTH

Job Type:

Permanent

Salary:

€ 35,000 - € 50,000

QUALITY AUDITOR ROLES FOR 3rd LEVEL DEGREE QUALIFIED SCIENTIST WITH 6+ YEARS AUDITING EXPERIENCE WITHIN PHARMACEUTICAL ENVIRONMENT. THESE ROLES CAN BE BASED FROM DUBLIN OR MAINLAND EUROPE AND WILL INVOLVE UP TO 50% TRAVEL.

RESPONSIBILITIES
• Prepare and conduct internal and external audits
• Perform independent research of required topics
• Provide independent review, comprehension, and discussion of policies and procedures
• Provide interpretation of complex regulations
• Manage the opening and closing audit meetings with all levels of Management.
• Perform GXP audits based on a defined audit plan within specific time constraints.
• Prepare all associated documentation including audit plans and audit reports
• Provide guidance and support in the development of corrective actions based on GXP
• Track and monitor audit responses and the implementation of corrective actions.
• Serve as a compliance reference
• Serve as a liaison within the many GXP departments
• Plan, schedule, and arrange travel to various sites based upon guidance from Management.

SKILLS
• 3rd Level Science Degree
• 6+ years of Quality Auditing experience within Pharmaceutical is required.
• Experience of national and international cGMP regulations
• Must be familiar with all other GXP concepts.
• Strong written and oral communications
• Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application.
• Must be adept at independent decision-making.
• Working knowledge of Microsoft Office including Word, Excel and Lotus Notes.
• Ability to travel up to 50% of time.

Contact Conor McGennis, SIGMAR RECRUITMENT, +353 1 4744695

Or send CV in strictest confidence cmcgennis@sigmar.ie

Your details will not be submitted for this or any other role without your expressed permission