Quality Systems Team Leader

Quality Start
From £30,000 to £38,000 per annum Bonus, Life insurance, Pension, ESPP
13 Oct 2016
25 Oct 2016
Contract Type
GMP Quality Systems Team Leader Opportunity – Hertfordshire Opportunity : This is a great opportunity you do not want to miss out on.If you are looking for a new change and career development then this is the role for you. Your role as a Quality Assurance (QA) Systems Team Leader based in Hertfordshire will involve working with the Quality Manager and the Quality team to develop and maintain an effective and compliant Quality System for the site. This will be achieved through the operational execution of key elements of the Quality system, including document control, QS training, change control, Non conformance investigation and CAPA, customer complaints, to maintain compliance with ISO 13485 and FDA (21 CFR) part 820 requirements. This is a senior role within the quality assurance function and you will be expected to deputies for the Quality Manager. Duties and responsibilities will include: Direct line management for the QS Documentation Controllers and Training Coordinators. Maintenance of the document control system - paper and electronic. Co-ordination of document control activities in accordance with the company quality system compliance program. Subject Matter Expert for the change control process. Collection, monitoring and trending data to support the Management review process and continuous improvement of the quality systems. Training employees in quality assurance. Supporting internal audit and supplier audit programs. Supporting incoming Notified Body and Regulatory Authorities inspections. Supporting product label approvals for new or existing product changes. This is a full time permanent role with a great salary of £30,000 - £38,000 per annum and excellent benefits including 5% discretionary local bonus, Life insurance, Pension, ESPP and 25 days holiday plus bank holidays on top. Skills: To apply for the role of Quality Assurance Team Leader you will have the following: Degree or equivalent qualification in a scientific or technological subject with team leader / management quality assurance expereince within the medical device / pharmaceuticals, or a related regulated environment. Working knowledge of both drug and device regulations, including 21 DFR Part 11 and 820, ISO 13485 and medical device directives. Experience in the Quality assurance of pharmaceuticals / medical devices or related regulated environment (GXP Compliance). How to Apply: To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. My contact details are: Miss Rashida Khan 0113 225 1547 If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information. For a list of our current vacancies, please visit www.qualitystart.co.uk If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role. Quality Start are acting as a specialist recruitment consultancy for this role. This job was originally posted as www.totaljobs.com/job/66881770