Quality Assurance Specialist
Posted 1 day ago by 1753971114
Negotiable
Undetermined
Remote
Remote
Summary: The Quality Assurance Specialist role is a remote position focused on supporting pharmaceutical projects, specifically in the veterinary vaccine sector. This 6-month contract involves ensuring compliance with regulations, managing deviations, and overseeing quality performance. The position requires a blend of analytical expertise and experience in manufacturing operations related to biologics and vaccines. The role is essential for maintaining high standards in product quality and regulatory compliance.
Key Responsibilities:
- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations
- Review and approve change controls
- Manage routine and complex deviations and complaints and assist in the coordination of significant investigations
- Conduct routine and solve complex analytical change requests and support process modification change controls
- Stability Program management, including review of stability reports, and Annual Product Review assembly
- Provide on-site guidance in the preparation of metrics, procedures, and guidelines
- Track and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plans
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration
- Responsible for shipment under quarantine
- Support routine process validation; review and approve validation reports/tech transfer
- Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes
Key Skills:
- Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience
- Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ)
- Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards
- Quality Risk Management (QRM) Experience
Salary (Rate): undetermined
City: undetermined
Country: undetermined
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Quality Assurance Specialist - Remote Working - 6 Month Contract
Do you want to be involved with exciting pharmaceutical projects?
When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Quality Assurance Specialist for a 6 months maternity cover.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations
- Review and approve change controls
- Manage routine and complex deviations and complaints and assist in the coordination of significant investigations
- Conduct routine and solve complex analytical change requests and support process modification change controls
- Stability Program management, including review of stability reports, and Annual Product Review assembly
- Provide on-site guidance in the preparation of metrics, procedures, and guidelines
- Track and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plans
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration
- Responsible for shipment under quarantine
- Support routine process validation; review and approve validation reports/tech transfer
- Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes
- Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience
- Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ)
- Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards
- Quality Risk Management (QRM) Experience
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