Job Description
As the Operations Systems Coordinator, you will be responsible for developing, managing, and improving systems that drive excellent performance across a balanced scorecard of safety, quality, delivery, continuous improvement, and people within the MeiraGTx Manufacturing organisation.
Main Activities
* Responsible for safety, compliance, and delivery systems management within manufacturing, including but not limited to:
1. Tracking of Eco Online KPI's
2. GMP Document flow for batch release - BMRs, forms, Logbooks, Protocols etc.
3. QE tracking and completion
4. MIAFs Tracking and completion of walk round and internal observations outcomes/actions.
Key Performance Indicators
* On time delivery of manufacturing system outputs e.g. Eco Online KPI's and BMR sign off.
* On time closure of GMP compliance records within own area of responsibility e.g. (but not limited to) Issues, CAPAs, Change Controls & audit/inspection actions.
* Assigned projects delivered to agreed schedules.
* Quality performance of Manufacturing including compliance KPI and monitoring systems kept up to date.
* Self development and training.
Key Job Competencies
* Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives.
* Systems thinking - understands interrelationships between activities and systems and optimises ways of working to deliver the best overall results.
* Data driven - highly proficient in acquiring, manipulating and analysing data to support performance improvement.
* Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations.
* Influencer - understands how to influence people with diverse backgrounds at different levels of the organisation to adopt better approaches consistently.
* Change management - capable of planning and executing change in a way that people understand and adopt into their daily work.
* Leadership - exhibits confidence in self and others.
* Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
* Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
* Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
* Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
* Oral Communication - listens and gets clarification; responds well to questions; demonstrates good presentation and communication skills; participates effectively in meetings.
* Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
Qualifications
University degree or HNC/HND in Science or Engineering.
Experience in pharmaceutical product manufacture.
Background in manufacturing operations and quality systems.
Ability to work collaboratively with colleagues and peers from a range of functions and backgrounds in a results-driven, team-oriented environment.
Good understanding of GMP.