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SENIOR QUALITY ASSURANCE SPECIALIST
Company:RECRUITMENT PLUS |
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Job Reference Number |
14565302 |
Client ID: |
RI/D003273 |
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Posted On: |
Feb 3 2012 |
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Location: |
DUBLIN SOUTH |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Benefits: |
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The Senior QA Specialist will ensure that all appropriate batch related documents and finished product packs are available from the contractors/suppliers to enable the release of products for sale or supply to global market, in line with business plans.
Successful candidate will be at least degree qualified in scientific discipline and will have at least 5 years experience in a similar type of role. Strong knowledge and previous GMP experience and will be familiar with EU/US GMP regulations.
Location: Dublin
Responsibilities
- Perform batch record review and release in an efficient and timely manner; assure non-conformances are properly investigated and explained, and calculations are correct. Assure that finished product is not released until the appropriate release testing and batch record review has been performed.
- Review finished product packs and batch documentation and check against the registered specifications prior to market release or advising rejection of a batch.
- Track and evaluate any investigations or deviations that occur during the manufacture of GMP material. When the non-conformance is more serious, bring it to the manager’s attention and aid in requesting a plan of action for a more extensive investigation.
- Assist with ensuring change control requirements impacting batch release are met.
- When appropriate, assist in internal GMP audits, and regulatory inspections.
If you are interested in the above role please contact Zuzana Foley now on 0429356910 or email your update CV to zuzana@rplus.ie
Please note all applicants will be dealt in strictest confidence.
RecruitmentPlus
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