Scientific Technical Leader I (Research)

A leading pharmaceutical client is searching for a Quality Assurance Associate to join their team in Hertfordshire. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe. This is a fixed term contract, lasting for 12 months.

Job Responsibilities:

• Reviewing EML and Third-Party Packaging Batch Records and associated documents and approving intermediate products.
• Reviewing and approving EML and Third Party Manufactured Bulk Batches.
• Supporting the approval of new and updated EML and Third-Party Master Batch Records and any other associated documents.
• Supporting the collection of data for reporting QA Performance Indicators.
• Acting as QA Representative within Production Operations.
• Supporting approval of SAP Material Master data, Bills of Material (BOMs) and other SAP related processes.
• Supporting the QA review and approval of appropriate QC documentation.
• Writing all SOPs associated with QA activities relating to product support.
• Completing the Quality Approval of SOPs.
• Participating in the internal and external audit process and support competent authority inspections.
• Raising and supporting the investigation of incidents, deviations and associated CAPA's
• Completing the QA Assessment of Deviations and CAPAs.
• Raising and supporting the investigation of customer complaints.
• Supporting the implementation of Change Control activities.
• Reviewing qualification/validation protocols, reports and associated documents.
• Supporting technology transfer projects and new product introduction.
• Supporting GDP activities such as assessing returned product, temperature excursions.
• Maintaining current TSE files on each marketed product.
• Representing QA on EML Work Equipment Teams and Continuous Improvement projects.
• Supporting the testing of the effectiveness of EML's EU product recall procedures on an annual basis.
• Identifying and implementing Continuous Improvement opportunities that result in cost savings and more efficient and compliant ways of working.
• Providing support to other members of the QO team, as appropriate.
• Performing any other appropriate duties at the request of the Quality Assurance Manager and EMEA Quality Operations Senior Director, EML

Skills and Requirements:

• A relevant degree.
• Demonstrable experience in a previous role.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Leoca Powell at +44 203 854 2624 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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