Proclinical is advertising a vacancy for a Senior QA Associate position an internationally known pharmaceutical company that develops and produces medicines and vaccines for a wide range of therapeutic areas, including oncology, cardiology, and immunology. The position will be based in the company's office in Hertfordshire and represents an exciting opportunity to work with a historic company with more than 150 years in business.
The Senior QA Associate will ensure that Quality Assurance activities relating to product support for the manufacture, packaging, testing, storage, and distribution of EML and Third Party manufactured drug products are compliant with current GMP and company expectations. They will provide input into the enhancement of quality policies, systems and procedures as appropriate. Finally, the Senior QA Associate will guarantee the integrity of EML's QMS and processes to support the cost-effective provision of product and services, whilst ensuring that operations carried out in accordance with the requirements of the company Quality System, GMP Guidelines, and Industry Standards.
Job Responsibilities:
- Deputing for the QA Manager when required.
- Coordinating technology transfer projects, new product introduction, or other business driven projects.
- Acting as QA lead on local, regional and global projects.
- Working with other departments to ensure a strong QA culture throughout the business and providing guidance.
- Acting as QA Representative within Production Operations.
- Reviewing EML and Third-Party Manufacturing and Packaging batch records, and associated documents and approving intermediate products.
- Reviewing and approving new and updated master batch records, associated SAP data, and any other associated documents.
- Resolving all quality issues to maintain product flow across the global business.
- Providing QA oversight and support for QC activities.
- Writing, facilitating the review, and obtaining agreement on all SOPs and training associated with QA activities.
- Participating in internal and external audit process and support competent authority inspections.
- Raising and coordinating the investigation of deviations, incidents, and associated CAPA's.
- Raising and supporting the investigations of customer complaints.
- Coordinating the implementation of Change Control activities.
- Completing quality or sponsor assessments of Change Controls.
- Reviewing qualification/validation protocols, reports, and associated documents.
- Coordinating QA support for GDP activities such as assessing returned product and temperature excursions.
- Representing QA on EML Work Equipment Teams and Continuous Improvement projects.
- Testing 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 and coaching to other members of the QO team, as appropriate.
- Performing any other appropriate duties at the request of the Quality Assurance Manager.
Skills and Requirements:
- A Bachelor's degree.
- Extensive knowledge and experience of Quality Assurance, Quality Systems, GMP guidelines, and an understanding of the manufacture and packaging of pharmaceutical products.
- An ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations, and other customers.
- Good technical and scientific judgement.
- Ability to interpret complex data and present key findings.
- Able to act as a mentor in support of QA staff development.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in 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 Katty Maia at + 44 2038543317 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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