Looking to use your technical expertise to ensure QC equipment and systems remain inspection‑ready and future‑proof?
Proclinical is seeking a Senior QC Equipment Technical Specialist to support the lifecycle management of Quality Control equipment and electronic systems within a laboratory environment. This role involves ensuring compliance with current Good Manufacturing Practices and supporting technical developments, procurement, validation, and training activities.
Responsibilities
* Manage and maintain QC laboratory systems and software to ensure compliance with cGMP and internal procedures.
* Lead qualification and validation processes for QC equipment and systems in line with industry standards.
* Support procurement and forecasting for new or replacement lab equipment and software.
* Develop and maintain procedures for system backup, archiving, and data retrieval.
* Troubleshoot and resolve technical issues, escalating as needed.
* Coordinate system updates and upgrades with external providers and internal IT teams.
* Provide training and guidance to QC team members on specialist equipment usage.
* Lead method transfer projects with third‑party contract laboratories.
* Prepare and update Standard Operating Procedures (SOPs) and training materials.
* Generate reports and Key Performance Indicators (KPIs) related to system administration activities.
* Identify and implement continuous improvement opportunities for more efficient and compliant operations.
* Respond to global regulatory queries regarding equipment and methods.
Key Skills and Requirements
* Strong knowledge of pharmaceutical QC equipment, electronic systems, and validation processes.
* Familiarity with Computer System Validation (CSV), GAMP guidelines, and data integrity principles.
* Proficiency in analytical software and electronic quality systems.
* Ability to interpret complex data and present findings clearly.
* Excellent communication and project management skills.
* Competence in Microsoft Office tools (Word, Excel, PowerPoint).
* Thorough understanding of GMP guidelines and regulations.
* Problem‑solving, decision‑making, and time‑management capabilities.
* Attention to detail and ability to work collaboratively within a team.
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