QA COMPLIANCE SPECIALIST
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Job Reference Number |
14564894 |
Client ID: |
RI/JO-1201-240588C |
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Posted On: |
Feb 2 2012 |
Location: |
TIPPERARY |
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Job Type: |
Permanent
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Salary: |
NOT DISCLOSED |
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CPL Cork has been retained by one of their key clients to partner in the sourcing and selection of a QA Compliance Specialist.
Duties and Responsibilities: · Assess compliance systems on ongoing basis to identify opportunities for process improvement
· Ensure quality issues are communicated to the management team such that they are aware of any significant variance from targets or potential opportunities or problems.
· Ensure efficient Regulatory and Change Control procedures exist and are implemented to ensure compliance with product licenses.
· Ensure preparation and approval of Product Quality Reviews is conducted in a timely manner.
· Ensure qualification of selected vendors and manage on-going vendor quality performance.
· Schedule and perform Supplier audits (Printed packaging material, API's, contract laboratories, warehouses, manufacturers etc).
· Ensure that internal audit of all six quality sub-systems at sites are conducted as per schedule and audit findings are addressed in a timely manner
· Coordination of vendor complaints and ensure timely and satisfactory resolution of same.
· Provide a supporting role during supervising authority (IMB), corporate and customer audits.
· Prepares and provides training in GMP to all site personnel.
Candidate Requirements
· A minimum of a B.Sc in Chemistry or equivalent and 3+ years experience in a compliance/QA or regulatory role in a Pharmaceutical environment
· Knowledge of QC/QA processes, relevant countries' regulatory requirements and internal QS policies and procedures.
If you are interested in hearing more about this opportunity, please call Rory Walsh, Senior Recruitment Consultant, for a confidential discussion on 021 4626112, or send your cv to rory.walsh@cpl.ie .
If you are not interested in this role but you would like to hear about future opportunities in the Pharmaceutical and Biotechnology Industries in Munster, please feel free to send your cv to rory.walsh@cpl.ie .
I will look forward to hearing from you.