The primary responsibility of this position is to ensure that software used by ULG (either purchased or internally developed) is validated as
per the software validation policy and fully meets the regulatory requirements.
Essential Duties + Responsibilities:
- Prepare software validation plans in accordance with the software validation policy, including but not limited to IQ, OQ, PQ details, acceptance criteria etc.
- Work with the IT Project Manager\BA Lead to verify that upcoming development is adequately risk assessed before determining
the appropriate level of validation.
- Ensure the validation software listing is up to date, controlled and correctly outlines the GCP\non-GCP assessment.
- Liaise with business SME’s to ensure appropriate validation is completed as per requirements for non-customized software.
- Designing and developing test cases.
- Execute test scripts while capturing test evidence.
- Ensure highest quality level of testing by applying a strict quality control process for all projects.
- Work closely with business stakeholders to ensure they have the required information before requesting deployment sign-off.
- Prepare software validation reports.
- Verify that all software validation projects adhere to company policies, including the 21CFR policy.
- Involvement with company ISMS program will be required. Tasks will include CAPA management, creating updates to the security policies, updating ISMS risks and objectives as required etc.
- Other duties as may be reasonably requested from time to time.
Education, Experience + Skills:
- An IT or Computer-related qualification or relevant work experience
- Strong background in software validation and the corresponding management of protocols
- Experience with 21CFR is an advantage
- Experience with Information Security Management System (ISMS) is an advantage
- Good written and verbal communication skills required
- Adaptable and flexible to changing work environment
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