Job Title: Quality Operations Associate
Job Type: 12-month Fixed Term Contract (FTC, MAT Cover)
Location: Hertfordshire, UK – On-site
Supporting Quality Systems and Assurance activities for the manufacture, packaging, testing, storage and distribution of onsite manufacturing and third party contract manufactured drug products, ensuring compliance with current GMP, Quality Systems, Corporate expectations and Industry Standards Support the review and writing of quality policies, systems and procedures as required.
Support the effective implementation, by all stakeholders, of aspects of the operational Quality Management System (QMS), including, but not limited to, Product Quality Reviews, Quality Agreements, Parallel Imports, Change Control, Risk Management, Deviations/Incidents, Training, Documentation, Internal and External Audits, Approved Supplier Systems and use of the TrackWise eQMS.
Responsibilities:
* To ensure that operations conducted are performed in accordance with the requirements of Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards.
* To support the Product Quality Review process for EML.
* To support the process of generation of Quality Agreements.
* To support the process for approving suppliers and the maintenance of the Approved Suppliers List.
* To support the maintenance of a list of Parallel Importers/Distributors of products as compiled from notifications and samples received by Regulatory Affairs.
* To support the generation of the Quality Management Systems Indicator reports.
* To be the quality point of contact to support factory operational departments with their creation/progression of quality records within the company QMS.
* To act as QO Representative within Production Operations.
* To review Third Party Packaging Batch Records, associated documents and to approve intermediate products.
* To review and approve Manufacturing and Third Party Manufactured Bulk Batches.
* To support approval of new and updated and Third-Party Master Batch Records and any other associated documents.
* To support approval of SAP Material Master data, Bills of Material (BOMs) and other SAP related processes.
• To support the QO review and approval of appropriate QC documentation.
* To complete the Quality Approval of SOPs.
* To participate in the internal and external audit process and support competent authority inspections.
* To raise and support the investigation of incidents, deviations and associated CAPAs.
* To complete the QA Assessment of Deviations and CAPAs.
* To raise and support the investigation of customer complaints.
* To support the implementation of Change Control activities.
* To review qualification/validation protocols, reports and associated documents.
* To support technology transfer projects and new product introduction.
* To support GDP activities such as assessing returned product, temperature excursions.
Skills / Qualifications:
* 1 to 2 years of experience in a previous QA role.
* Ability to establish and maintain effective working relationships and communication links within the business, affiliated organisations and other customers.
* Basic knowledge of Quality Systems, Quality Assurance, GMP and basic understanding of manufacture and packaging of pharmaceutical products
* Good technical and scientific judgement
* Ability to interpret complex data and present key findings
* Computer literate e.g. Word, Excel and PowerPoint
* Basic understanding of GMP Guidelines and Regulations
For more information, please reach out to lucy.kirkaldy@cpl.com