Job Summary
We are seeking an accomplished QC Instrumentation Analyst to join our team. In this role, you will be responsible for managing and coordinating laboratory instrumentation calibration and qualification programs.
The ideal candidate will have a strong background in analytical science, chemistry or a related discipline, and at least 3 years of experience working in the pharmaceutical industry. They will also possess excellent communication skills, with the ability to collaborate cross-functionally with various teams.
Responsibilities:
* Manage and coordinate laboratory instrumentation calibration and qualification programs.
* Prepare, review and approve validation protocols and reports for QC instruments and systems.
* Manage change-control activities for instrument installations, relocations, decommissioning and new purchases.
* Oversee GMP documentation, ensuring traceability, data integrity and audit readiness.
* Review and close unplanned maintenance and deviation reports, implementing effective CAPAs.
* Lead or support system-validation and requalification activities in alignment with GAMP 5 and regulatory guidelines.
* Troubleshoot laboratory instrument and software issues and coordinate with vendors for resolution.
* Develop, update and maintain SOPs and technical documentation for laboratory equipment.
* Support internal and external regulatory audits as the SME for QC instrumentation and validation.
Requirements:
* Bachelor's degree in Analytical Science, Chemistry or a related discipline.
* A minimum of 3 years of experience working in the pharmaceutical industry.
* Knowledge of Quality Control operations and understanding of GMP in a regulated environment.
* Experience preparing for and participating in Regulatory and Customer audits (FDA, HPRA, etc.).
* Experience in Equipment Validation and Change Control procedures is desirable.
* Strong ability to manage multiple tasks or projects, prioritize work and meet timelines for equipment calibration, maintenance and testing.
* Proven ability to collaborate cross-functionally with QAS, IM and multiple vendors.
* Highly motivated, strong teamwork and problem-solving skills, with a record of success in a collaborative laboratory environment.