KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior QA Officer will be varied however the key duties and responsibilities are as follows:
1. You will maintain the change control system, raise and investigate customer complaints and quality incidents. This will also involve agreeing actions in response to quality events, such as deviations, customer complaints, GDP incidents, and controlled changes.
2. As the Senior QA officer you will generate all QA documentation for the release of products, including Certificates of Analysis, Batch Protocols and Plasma Quality Certificates. This will involve coordinating the batch release process to ensure continued cGMP compliance, and supporting the QP prior to final product release.
3. Assist the site archivist in managing the GXP archive, maintaining an electronic register of all controlled documents, you will also be responsible for issuing and reviewing SOP's. You will review and update Technical Documentation including deviation reports.
4. You will provide training on Quality Systems, and monitor other departments ensuring continued GMP compliance across the site. You will conduct customer and regulatory audits, taking ownership of Quality Assurance in all areas.
To be successful in your application to this exciting opportunity as the Senior QA Officer we are looking to identify the following on your profile and past history:
1. Proven industry experience of over 5 years in Quality Assurance working within a Pharmaceutical QMS system.
2. A working knowledge and practical experience with GMP guidelines. Experience of working in an sterile manufacturing facility would be advantageous.
Key Words: Pharmaceuticals | GMP | cGMP | Quality Assurance | QA | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate | Aseptic | Biologics | Quality | Investigations | Senior | QA Lead | QA Officer | Technical Document | Audit | Investigation | Internal Audit | In-Process Checks | Clean-Room |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.
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