Your mission
As the Operations Compliance Specialist, you will be responsible for developing, managing, and improving systems that drive excellent performance across safety, quality, delivery, continuous improvement, and people within the MeiraGTx Manufacturing organization.
Job Description
Major Activities:
* Manage safety, compliance, and delivery systems within manufacturing, including tracking Eco Online KPIs, GMP document flow for batch release (BMRs, forms, logbooks, protocols), and QE tracking.
* Oversee MIAFs, walk round and internal observation outcomes/actions, and performance monitoring for GMP compliance.
* Assist in process improvements, document updates (SOPs, BMRs, WIs), and ensure GMP, Data Integrity, and GDP compliance.
* Ensure GMP documentation (issues, CAPAs, change controls, audit actions) are closed timely and correctly.
* Complete training in a GMP-compliant manner before task execution.
Key Performance Indicators:
* Timely delivery of manufacturing outputs and closure of GMP records.
* Project delivery according to schedule and up-to-date quality performance monitoring.
Key Job Indicators:
* Effective planning, systems thinking, data analysis, problem-solving, influencing, change management, motivation, professionalism, quality management, innovation, communication skills.
Qualifications:
* Degree or HNC/HND in Science or Engineering.
* Experience in pharmaceutical manufacturing and quality systems.
* Knowledge of GMP and ability to collaborate across functions.
Why us?
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