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Hyper Recruitment Solutions are currently looking for a QMS Specialist to join a leading Data Healthcare company based in the Greater London area. As the QMS Specialist you will be responsible for maintaining a validated and GxP compliant computerised system as well as preparing company policies and procedures to develop GxP compliant software for provision to the Pharmaceutical/Medical Device industries.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QMS Specialist will be varied however the key duties and responsibilities are as follows:
1. You will take responsibility for the continuous improvement of a QMS system, ensuring implementation and maintenance of policies to control validation of software applications and qualification of hardware infrastructure to develop GxP compliant software.
2. The QMS Specialist will take responsibility for ensuring software applications are validated and developed in accordance to regulatory standards and a defined Software Development Life Cycle (SDLC), this will include reviewing and approving changes to computerised systems through a change control process.
3. You will be responsible for the maintenance of a Validation Master Plan, including conducting periodic reviews of the status of the computerised system and the generation and execution of Validation Protocols, with the aim of ensuring that all IT Infrastructure is qualified to regulatory standards.
4. As a QMS Specialist you will play an active role in the process of the business achieving CE Mark status, as well as being the subject matter expert on CSV/Quality Risk Management for computerised systems. You will assist in customer/regulatory audits responding to observations and CAPA's when pertaining to Computer System Validation.
To be successful in your application to this exciting opportunity as the QMS Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences subject
2. Proven industry experience in Quality Systems application to Software development industries.
3. A working knowledge and practical experience with GxP guidelines, and the ability to initiate and work closely with third parties. Specific expertise with GCP guidelines would be advantageous.
Key Words: GMP | Quality Assurance / CSV / Computer Systems Validation / Systems Validation / Software Validation / GAMP5 / Pharmaceutical / GMP / GxP / ERP System / SAP System / SDLC / Software Development Life Cycle / Infrastructure / QA / Life Sciences / Biotechnology / IT QA / Systems Validation / SDLC / CE Marking / Software Quality Assurance / GxP Compliance / Regulatory Standards / Due Diligence / Hardware Infrastructure / Medical Devices / Audits / Quality Risk Analysis / Validation Protocols / Validation Master Plan / GCP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.