SRG Ireland has partnered with a Pharma company in Dublin to hire a Production Specialist.
Responsibilities include overseeing operations, excluding calibration scheduling, monitoring EMS, addressing anomalies, reviewing batch documents, handling quality investigations and risk assessments, identifying root causes in quality incidents, organizing and maintaining GMP documentation, managing Operations change controls, updating training matrices and programs, performing Production and Warehouse Product Quality Reviews, regularly auditing GMP and safety compliance, conducting Environmental, Health, and Safety Audits, reporting on Operations metrics and suggesting enhancements, engaging in improvement/compliance projects for better GMP and safety, training staff on cGMP documentation practices, and representing operations in regulatory and internal audits.
Key Skills and Qualifications
* Familiarity with QA methodologies
* Experience in regulated manufacturing (3+ years)
* Quality Systems expertise
* Technical Documentation experience
* Ability to train staff on cGMP documentation
* Confidence in representing operations during audits
Benefits of this role include a competitive salary, comprehensive benefits package, and the opportunity to work in a dynamic and challenging environment.
About the Job
This is a unique opportunity to join a team of professionals working in a fast-paced and rapidly evolving industry. As a Production Specialist, you will be responsible for ensuring that all operations are carried out safely and efficiently, while also meeting the highest standards of quality and regulatory compliance.