Job Purpose of the Quality Officer:
To perform QA activities across the business, supporting the overall quality management system, in accordance with ISO 9001 / GMP guidelines.
Key Responsibilities and Accountabilities of the Quality Officer:
- Maintain, monitor & review all QA activities in the site quality management system, driving quality compliance actions to completion.
- Batch document review and approval of final product to end markets.
- Provide QA approval on change controls, deviations, OOS, complaints.
- Provide support for internal and external audits.
- Generate quality technical agreements, using effective communication with end customers & distributors. Take part in customer meetings where applicable.
- Coordinate with the wider organisation on customer complaints, deviations & QMS related activities.
- Perform. review and approval of validation protocol and reports.
- Act as delegate for Quality manager in all QA aspects, where required.
Personal Specification of the Quality Officer:
- Experience of working in quality assurance roles, ideally in a GMP environment.
- Able to perform QMS activities across site (e.g., Deviation management, CAPA, Change control)
- Experience of review & approval of validation & qualification documents essential
- Confident in performing internal audits & hosting site audits with regulators & customers.
- Ability to prioritize workloads.
- Proficient communicator to all levels.
- Able to work quickly and accurately whilst maintaining identified quality standards.
- Good IT skills including Microsoft Word, Excel & Outlook.
