Business Analyst IT
|Title||:||Business Analyst IT|
|Sector||:||IT / Software|
Role of this position
- Provide technical support & solutions to the wider local site IT personnel to remediate existing Laboratory Computerised systems.
- Provide technical support & solutions to the wider local site IT personnel while introducing new Laboratory Computerised systems.
- Assist the wider local site IT personnel to maintain compliance to cGMP Computerised Systems Validation Regulations.
- Assist with planning, executing and documenting the full validation lifecycle for the first time qualification of new computerized laboratory equipment in a cGMP regulated environment.
- Assist with the development of Global Standards for backups, restore and disaster recovery of standalone lab systems.
- Assist with the development of Global Standards for setup and configuration of Lab software systems.
- Work with Vendors globally to ensure software is implemented in accordance with IT standards and understand how vendor software works in order to provide information to wider local site IT personnel, business owners and QA.
- Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirements and advise local site IT personnel, business owners and QA on best system to purchase.
- Ensure system compliance with Data Integrity standards and assist with remediation if required..
- Degree in Computer Science/Engineering/Pharmaceutical related Science/IT or relevant equivalent degree.
- 4 years + of Pharmaceutical industry experience that includes 2 years + related to PC based/Standalone Laboratory Systems.
- Knowledge of QC laboratory practices in a pharmaceutical Quality Control environment.
- Strong hands-on technical skills, operational background and working experience with infrastructure technologies and business applications.
- Experienced in providing technical solutions aligned with standards, security, validation, capacity, high availability and identifying associated risks.
Please call Michael Hanrahan today for further information on 021-2019817 or email: firstname.lastname@example.org