Reporting To: Quality Director
Contract Type: Permanent
Closing Date: Friday, February 7, 2020
The QA Officer is responsible for helping to administer the Quality Management System and helping ensuring it adheres to GxP activities and ISO standards This role is involved in the completion of internal audits, maintenance of the standard operating procedures and reporting of complaints and serious incidents to the customer as well as looking at opportunities for continuous improvement.
KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED
Please refer to the Person Specification.
PRIMARY DUTIES & AREAS OF RESPONSIBILITY
i) To provide high standard of administrative support to enable the Quality Department to work within a framework of continual Quality Improvement
ii) Assistance in creation of monthly quality business reports and assessing compliance to KPIs as required by the Quality Director
iii) Manage all aspects of Serious Incident Requiring Investigation (SIRI) investigation including follow up of QA tickets to ensure completion prior to Quality Director sign off
iv) To be responsible for maintenance of the ISO 9001 and GMP/GDP Quality Systems including training of staff in SOP’s, non conforming product investigations and management of deviations
v) Good knowledge/understanding of GMP regulations and guidelines
vi) To support Filling plant with investigations including scanning batch record paperwork to QP/Contract QP when they are offsite along with providing quality administration in the maintenance of the QMS system
vii) To investigate, resolve and report corrective and preventative actions as required, including logging and investigation of complaints and equipment issues using the QA ticket system.
viii) Provide assistance in management of ISO /GMP/GDP audits and creation of records as required.
ix) Performance of internal quality audits for ISO and GMP/GDP and where appropriate external audits for suppliers
x) To be involved in the participation and completion of agreed projects involving the Quality function to provide a quality input and help participate and complete any specific agreed project objectives.
COMMUNICATION & WORKING RELATIONSHIPS
Directors and Managers in all areas of the business
SPECIAL WORKING CONDITIONS
The postholder will be required to travel to external meetings on occasion
Dolby Medical Home
Respiratory Care Ltd
North Suite, Lomond Court,
Castle Business Park, Stirling,
Registered in Scotland
Southpoint, Old Brighton Road,
Gatwick, West Sussex,
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