Kenny-Whelan & Associates
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Quality Assurance Specialists
JO-1201-240953
investigation finished products Assurance Quality new product introduction Production batch Specialist review
Carlow
See description
4 - 5 Years
Contract
Third Level Degree
Carmel Egan
cegan@kenny-whelan.ie
Quality Assurance Specialists
In partnership with its client Kenny-Whelan & Associates is currently seeking a number a QA Specialists for the Carlow area.
The Client:
The Client is a well established multi-national.
Job Purpose:
The QA Specialist supports day to day QA activities in the site facility. The QA Specialist may participate as a core member of the Process Team that manages Vaccine and Biological product manufacture/as a member of the Quality Centre of Excellence (CoE) or as a member of the Quality New Product Introduction team.
Job Responsibilities:
1. Product Support
Process Team Member:
Participate as functional expert in the cross functional team that manages production of intermediates and finished products right first time at the site.
QA Support to Process:
- 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 positive feedback on re-occurring issues thus ensuring continuous improvement to the system. Carry out QA review and approval of the postproduction cleaning records for validation 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 trends during the batch manufacturing process.
- Attend cleaning meeting, review any cleaning investigations and ensure corrective actions are closed out. Review technical assessment and approve cleaning protocols.
Prepare Annual Process Reviews:
- Prepare & coordinate the review & approval of the Annual Product Review Schedule.
- Prepare annual process reviews for intermediates and finished bulk products as determined by the Annual Product Review (APR) Schedule.
QA Review of Regulatory Data:
- Review and verify Company documentation that may be used for submission. Assure the accuracy and integrity of all data and information through a timely review program.
New Product Introduction:
- Support the introduction of new products onto site in relation to Quality oversight, covering the end to end strategy.
- Participate in the Product Core Team meetings and facilitate the Quality Sub Team meeting. Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
- Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
2. Internal Audit Program Support:
- 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.
3. GMP Trainer
- Carry out GMP and compliance training for laboratory and plant personnel as required.
Job Requriements:
- 4-5 years experience working in a similar role within the pharmaceutical industry (biological background preferably)
- Degree qualified (Science related field) essential
All applications will be treated with the strictest confidence
Kenny-Whelan Contact:
For further information please contact Carmel Egan on 021 4665405 or send your updated CV to cegan@kenny-whelan.ie
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