Are you passionate about laboratory systems, data integrity, and driving compliance excellence in a GMP-regulated environment?
Proclinical is seeking a Senior QC Systems Technical Specialist to join our client's team. As a Senior QC Systems Specialist, you will be responsible for providing technical support for laboratory electronic systems used within the Quality Control function, including Laboratory Information Management Systems (LIMS) and Chromatography Data Systems (CDS).
You will support system administration, master data maintenance, issue resolution, compliance activities, and future system enhancements while ensuring adherence to GMP requirements, data integrity principles, and internal quality procedures.
Responsibilities:
- Maintain and update master data for QC electronic systems.
- Provide technical support for the operation, maintenance and continuous improvement of laboratory systems.
- Support the deployment, validation and qualification of new or upgraded systems.
- Generate, review and maintain qualification and validation documentation.
- Assist with system investigations, troubleshooting and issue resolution.
- Develop and maintain SOPs, work instructions and training materials.
- Support change control processes and system lifecycle management activities.
- Respond to regulatory and compliance-related requests concerning laboratory systems, equipment and methods.
- Identify opportunities to improve system performance, compliance and user experience.
- Champion data integrity principles and electronic system best practices.
Additional Responsibilities
All activities must be performed in accordance with company quality standards, GMP requirements, GDP requirements and applicable industry regulations.
Responsibilities include:
- Maintaining a safe working environment and reporting incidents in accordance with procedures.
- Supporting product quality through adherence to approved processes and procedures.
- Identifying opportunities for continuous improvement, innovation and cost efficiency.
- Ensuring customer and stakeholder expectations are understood and met through effective communication.
- Demonstrating behaviours aligned with company values and business objectives.
- Supporting compliance, quality and operational excellence across all activities.
Key Skills and Requirements:
- Degree or equivalent experience in a scientific discipline.
- Strong working knowledge of Quality Control laboratory electronic systems and their qualification and validation requirements.
- Demonstrable experience creating and maintaining master data within LIMS and/or CDS platforms in a regulated pharmaceutical environment.
- Experience using QC electronic systems as an end user.
- Strong understanding of GMP requirements and data integrity principles.
- Ability to analyse business and user requirements to support system enhancements and process improvements.
- Excellent communication and stakeholder management skills.
- Ability to establish effective working relationships across multiple functions and external partners.
- Sound technical and scientific judgement.
- Experience interpreting complex data and communicating findings clearly.
- Ability to explain technical concepts in a clear and practical manner.
- Proficient in Microsoft Word, Excel and PowerPoint.
- Highly organised, detail-oriented and capable of working independently.
- Strong problem-solving, decision-making and time-management abilities.
- Commitment to remaining current with developments in laboratory and electronic systems technologies.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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