
Quality Assurance Associate
- Watford, Hertfordshire
- Permanent
- Full-time
- Monitor and update training matrix and schedule, working with department managers and QA to ensure training is always up to date. • Monitor and update the Document Control Log. • Maintenance of documents (SOP’s, WI’s, Forms, Policies etc) within the Document Control Log, from training to effectivity and the final archiving and storage. • Support the QA department and RP with administration duties. • Participate in audit and inspection planning. • Support quality and compliance infrastructure development Change Control, CAPA and Deviation Management • Monitor, update and support Corrective and Preventive Action (CAPA) activity. • Work closely with other departments to facilitate actions and maintain compliance to the current systems for change controls, CAPA, deviations, complaints, internal GDP audit observation follow up. • Assist with quality incidents. Qualification and Compliance monitoring • Perform regular compliance checks from MHRA websites. • Perform internal compliance checks. • Carry out monthly compliance checks for import / export process. • Assist with temperature report retrieval, review, and closure. • Assist departments with customer and supplier bonafide checks • To administer the competence tests associated with SOP training. • To notify required members of staff of their requirement to complete a competency test, with reference to the training matrix. • To receive back, score and record, competence tests. • To notify line managers of any failures to achieve the required score and/or failure to complete competence tests in a timely manner.
- Previous QA experience in a GDP environment • Experience in utilising quality system processes (such as, Audit, Deviations, CAPA, Change Control) • Excellent administrative and people skills • Strong communication skills, with excellent English language skills, (oral and written) • A good team player demonstrating a willingness to learn, improve and adapt • Strong analytical and problem solving skills, with experience of route cause analysis • Excellent time management skills • Possess the ability to work productively and diligently, with initiative and drive, under tight timescales and pressure whilst maintaining attention to detail and high quality standards • Proficient in the use of MS Office applications, especially, Word, Excel and Power Point