IT Quality Assurance Manager
ProClinical is advertising a vacancy for an IT Quality Assurance Manager position with a global healthcare company that provides innovative, effective, and safe solutions that care for patients at every stage of life. The organisation is looking for a driven and ambitious applicant to join their team in Uxbridge. This is an exciting opportunity to join a renowned company and provide real experience and skills to a fascinating position.
The IT Quality Assurance Manager will be responsible for the compliance of selection, installation, validation, and maintenance processes and activities of GxP IT systems cross-functionally within the company.
- Advising on and implementing appropriate validation strategies for new IT systems, using risk management approaches:
- Electronic Quality Management System
- Artwork Management System
- Document Management System
- Retrospectively assessing existing IT systems and addressing any identifiable gaps.
- Qualifying and maintaining qualified status of all IT third party service providers.
- Maintaining Validation Master Plan for IT systems.
- Maintaining the validation status of IT systems throughout their lifecycle.
- Ensuring robust and appropriate policies and procedures are in place for key IT processes:
- Data Integrity
- Access Control/Security
- Incident Management
- Change Control
- Master Data Management
- Disaster Recovery
- Establishing a close working relationship with the IT department, system owners, and other internal stakeholders.
- Performing routine self-inspections of IT systems in conjunction with the company's QMS.
- Keeping up to date with the latest Regulations and supporting their implementation.
- Participating in Customer and Regulatory Authority inspections.
- Authoring and approving Standard Operating Procedures.
- Frequently travelling to the company's London office.
- Travelling to suppliers in the UK and EU when necessary.
Skills and Requirements:
- A degree or equivalent in a relevant scientific subject is desirable.
- Experience working in Quality Assurance within the Pharmaceutical industry.
- Extensive knowledge of and experience implementing validation of systems to GAMP 5 guide, Annex 11 of Eudralex Volume 4 & 21 CFR part 11.
- Working Knowledge of Pharmaceutical GxP regulations.
- Working knowledge of ERP systems in Distribution and Logistics environment.
- Proven record of experience working closely with IT technical team.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Mid-Senior Level.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden at +442038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
ProClinical is advertising a vacancy for a Senior IT Infrastructure Engineer position
ProClinical is advertising a vacancy for a Help Desk II position
Amsterdam, North Holland
ProClinical is advertising a vacancy for a CEMEA IT Lead Enterprise Systems position
Amsterdam, North Holland
ProClinical is advertising a vacancy for an IT Lead Supply Chain Management (SCM) Systems position
ProClinical is advertising a vacancy for an IT Business Analyst Senior position
ProClinical is advertising a vacancy for a Systems Developer - Edata Support & Operations
IT Service Desk Engineer
ProClinical is excited to announce that an opening for an IT - Business Analyst - Skill set 3 - Senior position
ProClinical is excited to announce that a new job opportunity has arisen for a Consultant - Information Management to join a one the largest CROs in the global market
ProClinical is happy to advertise that a medical research start-up has an opening for a Biostatisticien Senior job at their Paris office.
This is an attractive IT Support - Assistant Team Lead job vacancy at a global biotechnology innovator specialising in disease areas which have unmet medical needs.