IS Quality Analyst

We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation activities for IT systems and software applications. Additionally, you will provide technical support, collaborate with other IT teams, and drive continuous improvement initiatives.

*Key Responsibilities:*

*Quality *
* Lead and oversee the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines.
* Facilitate the effective management of deviations and CAPAs, ensuring regulatory compliance and continuous improvement. Additionally, you will play a pivotal role in overseeing change management processes, by assessing impacts, communicating changes, and adeptly managing stakeholder expectations.
* Develop and maintain IT quality procedures, policies, and documentation to ensure compliance with regulatory requirements.
* Support audits and inspections related to IT quality and regulatory compliance.
* Monitor and audit IT systems and data processes to ensure compliance with regulatory requirements.
* Lead validation activities for IT systems and software applications, including validation planning, protocol development, execution, and documentation.
* Provide guidance and training to IT staff and stakeholders on IT quality principles, practices, and regulations.
* Review and approve changes to IT data processes, and documentation to ensure data integrity and compliance with regulatory requirements.
* Manage IT projects, ensuring compliance with GMP guidelines, regulatory requirements, and industry standards
* Stay informed about industry trends, regulatory changes, and best practices related to IT quality and GMP compliance

*General IT *
* Technical Support: You will be responsible for providing technical support at all levels to end-users in the company, troubleshooting and resolving issues related to hardware, software, and network systems.
* Collaboration: Work with other IT teams, including infrastructure, networking, security, and applications, to resolve technical issues, implement changes, and optimise IT systems and services
* Mentoring and Training: You will provide guidance and support to junior IT staff, helping them develop their technical skills and knowledge.
* Continuous Improvement: Ongoing assessment of the company's processes, pinpointing areas for refinement, and executing strategic changes to enhance operational efficiency consistently.
* Continuous Improvement: Stay updated with technology trends, IT developments, and industry best practices, continuously enhancing technical skills and knowledge.

*Desired Competencies: *

*Technical *
* Bachelor’s Degree in Computer Science, Information Systems, or another related field. Or equivalent work experience with at least 3 years working in a regulated environment being particularly desirable.
* GAMP5 trained or equivalent experience.
* ITILv4 trained or equivalent experience

*Behavioural *
* Good understanding of a relative area of computerised systems or automated systems used within: Production, Packaging, Process control, IT systems, QC & Laboratory systems, Quality systems, Facilities)
* Ability to work and progress multiple validation projects and deliverables simultaneously.
* Ability to build and develop both formal and informal professional networks.
* Volunteers to identify and address existing and potential obstacles, issues, and opportunities.
* Collaborates with other members (local on-site IT Support, stakeholders, Corporate IT Infrastructure etc.) in the pursuit of common missions, vision, values, and mutual goals.
* Excellent communication skills: ability to articulate technical and business concepts, ideas, opinions, and conclusions orally and in writing.

Job Types: Full-time, Permanent

Benefits:
* Company pension
* Health & wellbeing programme
* Life insurance
* On-site parking
* Private medical insurance
* Referral programme
* Sick pay
Schedule:
* 8 hour shift
* Day shift
* Monday to Friday
Supplemental pay types:
* Bonus scheme
* Performance bonus

Application question(s):
* What are your salary expectations?

Work Location: In person

Reference ID: ISQL

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