Head of Quality and Regulatory Affairs
4 weeks ago
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
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