Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. This newly created role, QA Specialist will be responsible for performing key Quality tasks in respect of Company products. Work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions.
Reporting to the Director Quality Assurance.
Responsible for developing and maintaining Quality Systems and to ensure that all operations are fully in compliance with current international standards for cGMP.
The QA Specialist is responsible for to:
Managing the product stability programme
Investigating out-of-specification (OOS) reports & deviations
Act as lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance with requirements and country specific regulations.
Monitor the operations at the Contract Manufacturer. Perform batch review, review product complaints, deviations, change controls and product related investigations.
Be a key member of company audit team during regulatory or customer audits.
Support the product complaints system
Operate the CAPA system
Develop and write SOPs & controlled documents.
Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
Report Quality Metrics
Review and approval of product artwork
Assisting in preparation of Annual Product Reviews
Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA?s).
Work directly with other key Company departments to ensure compliance and productive working relationships.
Assist with troubleshooting quality issues at Partner?s or vendor?s site or associated with technology transfer, when required.
Maintain appropriate Quality Technical Agreements with all GxP vendors
Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
Contribute to management of the supplier approval programme and to maintenance of the external audit schedule.
Supporting regulatory submissions
Bachelor?s degree in chemistry, biology or a related discipline
Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
Experience with third party vendor auditing, out of spec investigations, change control
Thorough understanding of quality systems and cGMP?s
Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
Experience working with contract manufacturing
Experience interfacing with regulatory bodies or working on regulatory submissions
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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