Change Management Specialist
1 week ago
Company Description Integrity PM Ltd is a specialist Project Management consultancy supporting pharmaceutical and life sciences clients across Ireland. We deliver high-impact solutions in GMP environments, with a focus on manufacturing excellence, compliance, and strategic execution.
Role Description This is a contract role for a Change Management Specialist , based on-site in the West of Ireland (Midlands-adjacent). The Change Management Specialist will support the Manufacturing Department within an Oral Solid Dose pharmaceutical facility, following a series of engineering upgrades involving new containment equipment.
The role is embedded within Production and focuses on implementing a molecule-specific Change Control strategy. The successful candidate will be responsible for generating and progressing Change Control Forms (CCFs) per molecule, ensuring alignment with GMP, regulatory, and operational requirements.
Qualifications Experience in pharmaceutical manufacturing, ideally within Oral Solid Dose environments
Strong understanding of GMP, validation protocols, and regulatory frameworks (Medical & Veterinary)
Demonstrated experience in Change Control management and generation within GMP-regulated environments
Proven ability in technical writing, including SOPs, validation documentation, and regulatory submissions
Skilled in stakeholder engagement and cross-functional collaboration
Proficiency in documentation, traceability, and compliance systems
Ability to manage multiple product-specific workflows concurrently
Adaptability, critical thinking, and a proactive approach to problem-solving
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