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QUALITY ASSURANCE SPECIALIST X 4
Company:CPL |
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Job Reference Number |
14564917 |
Client ID: |
RI/JO-1201-240944I |
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Posted On: |
Feb 2 2012 |
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Location: |
NATIONWIDE |
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Job Type: |
Contract |
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Salary: |
NEGOTIABLE |
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(We have 12 X Quality Assurance/Compliance and Regulatory opportunities in Carlow, Tipperary and Cork for immediate starts so feel free to call me ( rory.walsh@cpl.ie ) on 021 4626112 for a confidential discussion)
Carlow QA Specialist opportunities
CPL has been retained by a number of multinational Pharma/Biotech key clients to partner in the sourcing and selection of 4 X Quality Assurance Specialists
QA Specialist - Carlow
Duties and responsibilities:
· Participate as functional expert in the cross functional team that manages production of intermediates and finished products right first time at the site.
· Participate in Company process reviews as the Quality Assurance representative. Ensure that quality issues are identified, addressed and resolved before production commences.
· Carry out the QA review and approval of postproduction process batch for validated steps prior to release of material by Quality
· Provide support to deviation investigations and process performance monitoring on a daily basis.
· Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed. Identification of repeat atypicals or trends during the batch manufacturing process.
· Prepare & coordinate the review & approval of the Annual Product Review Schedule.
· Review and verify Company documentation that may be used for submission to RAS-CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program.
· Support the introduction of new products onto site in relation to Quality oversight, covering the end to end strategy.
· Act as lead auditor to support the internal GMP audit schedule including preparation & approval of the internal schedule and the external suppliers audit schedule.
· Complete vendor audits as requested by the Divisional Audit group & aid in specific queries in relation to company related materials.
· Carry out annual GMP and compliance training for laboratory and plant personnel as appropriate.
· Act as mentor for new QA personnel playing a significant role as trainer and coach for the initial 6 - 12 months after employment.
Candidate requirements:
3-4 years experience working in a similar role within the pharmaceutical industry Degree qualified (Science related field) 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.
