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