RESPONSIBILITIES
Work with the Head of IT and senior managers to build on an existing compliance and information security program within IT projects that address information security risks and compliance requirements.
Maintaining GXP standards with the IT Department.
Participate in the preparation and management regulatory agency and client inspections.
Evaluation of compliance requirements with stakeholders including response to requirement specifications from companies departments.
Provide support by providing advice and facilitating the escalation of any compliance issues through the appropriate routes.
Ensuring the IT systems meets requirements in regard to 21 CFR Part 11, data integrity, Gamp 5, GMP, annex 11 (Computer Systems Validation), EU Directives.
Cross Training within the team to develop knowledge and understanding of IT (GxP) and Quality requirements.
Assisting with managing and overseeing the IT compliance and security aspects of the company / project IT set-up including websites that may be hosted internally or externally.
REQUIRED EXPERIENCE
- 6 plus years working within the Pharmaceutical industry with experience of Compliance, IT support, cyber security and service level agreements etc.
- Experience of GAMP 5 and working within a GxP environment. Experienced in providing superior customer service and support.
- Working knowledge of the Data Protection Act (1998) and General Data Protection Regulations (GDPR)
- Proven project management skills, including the ability to effectively deploy resources and manage multiple projects of diverse scopes in a cross-functional environment.
- Previous exposure to an R&D interfacing environment would be beneficial.
- Educated to Degree level in a relevant subject.
- Highly motivated, pragmatic and practical with a strong work ethic and eye for detail with good problem resolution, judgement and decision-making skills.
- Able to evaluate complex situations and find solutions for them in a professional manner.
- Proven project ownership and pride in its delivery.
- Flexibility towards work assignments and new learning.
- Ability to manage multiple and varied tasks and prioritise workload with attention to detail.
- Comfortable operating autonomously once goals and objectives are set.