*This is a remote opportunity*
An exciting contract opportunity within a groundbreaking big-pharma institution has become available! My client is looking for an experienced Quality Assurance Officer – to join the company on a remote 12month contractual basis ASAP.
This role has extensive scope and full responsibility and is an essential role for my client, this is responsible for compliance activities for GSQ supply chains and suppliers. You would be responsible for all Quality activities that directly support execution of assigned Quality Management System elements.
This will include, but is not limited to, the Quality System oversight and/or performance of the following activities:
- Product quality complaint, Temperature Excursions or S&L complaint management
- Deviation investigations, quality issue management and escalation
- Product release
- Change control
- SOP management
- Stability Data entry and management
- Supply Chain Assurance system administration
- Training System
- Quality Risk Management
Complaints Management – You will coordinate complaints issued for GSQ as a supplying site or coordinating site
- Product Quality Complaints
- Temperature Excursion
- Supply and Logistics (support when applicable)
- Product security
Supporting the GSQ Quality Management Systems
- Oversee and maintain quality data and records in relevant quality management support systems (GQCLIMS, SAP and OCM) as required.
- SCA data entry and checks
- Stability Data entry and secondary data checks
- Assists in the production of, or contribution to, my client’s quality documentation as GSQ SOPs.
- Manages internal deviations in Track wise deviation system.
Getting involved in Product Release – Vaccine products (in accordance with Manufacturing License),
- Batch record reviews (including certificates of analysis/conformance, assessment of deviations as required) including working in relevant quality management systems (SAP, GQCLIMS).
Skills, Qualifications and Experience required
- Bachelor degree in a science / technical / relevant field
- Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
- Strong knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
- Previous experience within a product release role
This is a fantastic opportunity which is a critical hire for my client, please send your CV and a cover letter to be considered for the role. Please allow 24 hours or 1 working day for me to review.
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