Job Description
Software Quality Engineer
Key Responsibilities:
- Site Subject Matter Expert (SME) person and co-ordinator for computer validation/test activities.
- Site SME for computer software validation (cave) during internal and external audits.
- Ensure regulatory compliance with internal and external validation regulations, particularly with corporate cave requirements.
- To co-ordinate activities relating to the implementation and maintenance of the Quality System in order to comply with Corporate, EC, FDA and Canadian requirements.
- Drive continuous improvement initiatives within the Quality systems department.
- Ensure relevant procedures are kept up to date and maintained to the relevant standards and to industry best practice.
- Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all cave applications.
- Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
- Determines Project schedules for remediation of legacy systems and works with cross functional teams to ensure adherence.
- Provides guidance, training and direction on cave to staff across various functions. Provide software validation/compliance/part 11 leadership.
- Take part in vendor audits of critical equipment vendors.
Education & Qualifications:
- Level 8 qualification in Information Technology/Computer Science or equivalent discipline.
- Preferable 2.5 years experience in a similar role, preferably in a large multinational company.
- Demonstrate strong communication and problem solving skills.
- Customer focused approach.
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