Blackfield Associates
Quality Information System Analyst
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Quality Information System Analyst
The Opportunity
We're looking for a Quality Information System Analyst to play a key role in supporting and enhancing critical manufacturing and quality systems within a highly regulated environment.
Working as part of the Manufacturing Business Systems team, you'll help drive digital transformation initiatives while providing ongoing support, optimisation and governance of business-critical applications.
Initially, your focus will be on Quality Systems, including LIMS, CDS and Quality Control laboratory applications, with opportunities to broaden your experience across manufacturing, warehousing and serialisation systems.
This is an exciting chance to combine technical expertise, stakeholder engagement and continuous improvement activities while contributing to the evolution of a smarter, more data-driven manufacturing operation.
Key Responsibilities
Business-as-Usual
- Support and maintain GMP-regulated IT systems and processes.
- Manage and resolve technical issues, incidents and service requests.
- Collaborate with infrastructure, security, networking and business teams to deliver effective solutions.
- Support deviations, CAPAs and change management activities.
- Author validation and technical documentation in line with regulatory requirements.
- Ensure data integrity, compliance and system lifecycle management.
- Support internal and external audits and inspections.
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Projects & System Enhancements
- Gather and translate business requirements into technical specifications.
- Support the implementation of new IT systems and applications.
- Participate in solution design workshops with stakeholders and vendors.
- Complete testing, validation and implementation activities.
- Lead smaller projects where appropriate.
- Ensure solutions align with GMP and cybersecurity best practices.
Continuous Improvement
- Identify opportunities to improve systems, processes and user experience.
- Support Smart Factory and digital transformation initiatives.
- Stay current with industry developments, regulatory updates and emerging technologies.
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What We're Looking For
Essential
- Experience supporting pharmaceutical quality, laboratory or manufacturing systems.
- Strong knowledge of LIMS, CDS and Quality Systems applications.
- Experience working within a regulated GxP environment.
- Knowledge of Computer Systems Validation (CSV) and system lifecycle management.
- SQL skills.
- Strong technical troubleshooting and problem-solving abilities.
- Excellent communication and stakeholder management skills.
- Ability to translate technical concepts for non-technical audiences.
- Self-motivated, collaborative and able to manage multiple priorities.
Desirable
- Degree in Computer Science, Information Systems or a related discipline.
- GAMP5 and/or ITIL experience.
- Pharmaceutical Quality Management Systems knowledge.
- Project management experience.
- Data management, analytics or database management experience.
- Agile methodology knowledge.
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