IT Quality Analyst, Senior Associate

An internationally known biotechnology company has an opening for an IT Quality Assistant, Senior Associate at their Maidenhead office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.

Job Responsibilities:

• Represent ITQ on cross-functional teams in support of SDLC activities for GxP applications, primarily focused on R&D systems. Drive the deployment of new or modified GxP systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.
• Perform and manage all supporting quality related activities associated with computerized systems including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc. for assigned systems in alignment with noted KPIs.
• Support all Global Quality initiatives, including Data Integrity, Computerized Systems and IT QMS implementation / remediation.
• Perform all assigned and required trainings to maintain 100% compliance.
• Support GxP audit readiness activities. Support internal and external audits/inspections as the IT Quality point of contact. Lead efforts to continue Compliance and Efficiency improvement.

Skills and Requirements:

• Bachelor's Degree in Life Sciences, Engineering or IT related discipline with relevant experience.
• A minimum of ten (10) years related experience and/or training with 5 years in a CSV / Quality role. Background in Lifesciences and/or Pharma/Biotech industries.

• Hands-on experience supporting implementation of computerized systems within a GxP environment either as a CSV and/or Quality lead.
• Ability to interpret regulatory guidance (GxP) and company policies and procedures into executable and defendable lifecycle documentation.
• Executable knowledge of respective regulations governing computer systems and controls such as 21 CFR Part 11, Annex 11, MHRA's data integrity guidance, etc.
• Understanding of risk-based methodologies as it relates to qualification and validation.
• Experience supporting health authority inspections.
• Knowledge of underlying infrastructure requirements supporting GxP systems.
• Knowledge of SaaS, AWS, etc. and the key compliance components.
• Experience supporting health authority inspections.

• 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.

To Apply:

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 Joshua 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.

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