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 Contec 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:
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. What we offer you:
A competitive salary. Discretionary (performance?) annual bonus. Private Medical Insurance for you and your family. Pension Scheme. Corporate benefits platform & Cycle to Work Scheme. Death in Service Benefit.
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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 Contec 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:
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. What we offer you:
A competitive salary. Discretionary (performance?) annual bonus. Private Medical Insurance for you and your family. Pension Scheme. Corporate benefits platform & Cycle to Work Scheme. Death in Service Benefit.
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