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Quality Systems Analyst Pharma, LIMS
4 months ago
- Job Type: Full-time
- Location: Hybrid working - Hatfield
- Salary Range: Competitive plus bonus, private healthcare/dental and more
We are seeking a Quality Systems Analyst to support the implementation and maintenance of IT systems and processes in compliance with GMP regulations and guidelines. This role is pivotal in ensuring the integrity and efficiency of my clients Quality Systems, including LIMS, CDS, and Quality Control Equipment Applications, as well as supporting broader IT functions across Serialisation, Warehouse, and Manufacturing areas.
Main Duties/Responsibilities:- Collaborate with the Team lead and other IT teams to resolve technical issues, implement changes, and optimise IT systems and services.
- Manage and respond to IT requests via the IT ticketing system, ensuring timely and effective resolution.
- Facilitate the management of deviations and CAPAs, supporting change management processes and stakeholder communication.
- Provide guidance to non-EML IT staff on GxP processes and to EML staff on IT best practices.
- Author validation documentation for IT change activities in line with IT and GMP standards.
- Ensure IT data processes and documentation maintain data integrity and comply with regulatory requirements.
- Support IT audits and inspections related to quality and regulatory compliance.
- Provide technical support for IT projects, ensuring alignment with GMP regulations and guidelines.
- Translate business requirements into solution specifications and participate in application design and development.
- Lead validation activities for IT systems and software applications, including planning, protocol development, and documentation.
- Test and implement new applications.
- Lead small projects as appropriate.
- Identify and address potential obstacles and opportunities for process enhancement.
- Assess and refine company processes to enhance operational efficiency.
- Stay informed about industry trends, regulatory changes, and best practices.
- Support smart factory initiatives and other teams where knowledge and skills are applicable.
- Proven experience in IT support within a GMP regulated environment.
- Strong understanding of Quality Systems such as LIMS and CDS.
- Experience with IT ticketing systems and change management processes.
- Ability to author and validate IT documentation in compliance with GMP standards.
- Knowledge of regulatory requirements and industry standards.
- Excellent problem-solving skills and the ability to lead projects.
- Strong communication and stakeholder management skills.
Apply now to be immediately considered.