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QA Associate-Audit-ISO13485-GMP-Herts-£25K-£30K-Perm

Permanent  for Cranleigh Scientific in Hertfordshire

QA Associate-Audit-ISO13485-GMP-Herts-£25K-£30K-Perm -CAPA-Change Control-QMS-Root Cause A growing medical device organisation producing medical products for the regeneration of tissue are at an exciting stage of growth. They require an experienced QA Associate to manage their quality management system and all quality operations. You will have previous QA experience within either a pharmaceutical or medical device industry. Quality Assurance Communication 1. Communicate with a wide range of individuals both internal and external to facilitate compliance with QA requirements appreciating differing points of view and managing conflicting priorities or antagonistic responses. 2. Present the outcomes of Quality Systems audits and other Quality Assurance information that may be sensitive and highly complex to a range of people and groups in a clear, concise and easily understood manner. 3. Maintain close liaison with key staff in all departments and provide the necessary technical advice and assistance to maintain compliance. Analysis 1. Correctly interpret complex guidelines and advise Departmental managers in order to establish compliance with legislation and accreditation requirements 2. Analyse complex events or deviation in order to identify the root cause. Quality incidents are multi faceted and evidence is often conflicting 3. Decide when to close deviations, request further corrective or preventative action, or escalate to a higher level within QA and highlight trends. 4. Review deviations and identify trends, initiating any required action. 5. Critically review change control plans and supporting documentation with departmental managers prior to changes in processes/procedures and judge whether any further actions are required to meet quality standards and GMP prior to implementation. Planning and organising 1. Contribute to change projects. 2. Participate in producing Quality plans and delivering Quality requirements to defined schedule. 3. Plan and organise a variety of complex programmes including specific training events related to quality issues 4. Organise and participate in supplier audits as directed by Site Qualified Person Human Resources 1. Assist the Technical Director in the management of the Quality Assurance department, including team briefing, Connect briefing, Personal Development Reviews, leadership, training, prioritising and planning workload and recruitment and selection. 2. Contribute to the co-ordination and delivery of training for Good Manufacturing Practise (GMP) and the application of company quality systems including auditing, event management, recalls and change control. Research and Development 1. Ensure that significant changes to quality systems are controlled according to company policies through the Change Control system,including the evaluation, approval of validated changes of equipment and processes and database amendments. 2. Take the QA lead on change projects or centre wide projects as directed by the Technical Director. Decision making/Freedom to Act Approve process deviations and concessions. 1. Take part in initiation of recalls and manage local completion recall and record trace activities. 2. Validate with departmental manager that due process has been undertaken prior to the release or rejection of cell therapy products for clinical use following an adverse incident. 3. Decide on the severity of deviation reported to Quality Assurance. Escalate major and critical deviation to Site Qualified Person and Technical Director. 4. Review investigations following Deviation, out of specifications , Audit findings and decide if the implemented corrective and preventative action is adequate to close the event or whether further action is required. Requirements: - Minimum of a BSc (Hons) ideally in a bio-based subject - Minimum of 2 years previous QA industrial experience - Working knowledge of GMP and IS0 13485 QA Associate - Stem Cells - Hertfordshire - £25k-£30k - Perm

Job added on 24-10-2014