Quality Assurance Systems Specialist
|Job Title:||Quality Assurance Systems Specialist|
|Contact Name:||Laurentina Kennedy|
|Job Published:||almost 2 years ago|
The QA Systems Specialist will be responsible for performing key Quality tasks in respect of Company products. You will work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions.
The QA Systems Specialist will be responsible for developing and maintaining Quality Systems and to ensure that all operations are fully in compliance with current international standards for cGMP.
Provide oversight and management of components of the Quality Management System (QMS), which consists of, Change Controls, Deviations, CAPAs, Complaints, Documentation and Vendor Management.
Is proactive in looking for continuous improvement opportunities within the QMS.
Be a key member of company audit team during regulatory or customer audits.
Implement and improve Quality Systems to realise the highest quality standards attainable for all activities conducted by the company.
Act as a lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance with company requirements and country-specific regulations.
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).
Compile and manage Quality Systems metrics. Work directly with other key Company departments to ensure compliance and productive working relationships.
Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
Contribute to the management of the supplier approval programme and to the maintenance of the external audit schedule.
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
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 Systems Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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