Description
A Global Pharmaceutical organisation currently requires an experienced QA Specialist to be based at their facility in Ireland, working on their new refurbishment project - Removing current utilities and manufacturing lines and installing new utilities and a dry powder inhaler line.This person will serve as the Quality reviewer and approver on project milestones and documentation such as risk assessments, commissioning, qualification, and validation activities.
Key Responsibilities:
•Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
•Review and edit project documentation ensuring that Quality requirements are met
•Provide QA approval on finalised project documentation
•Contribute to equipment and process risk assessments
•Provide QA oversight for equipment qualification and commissioning activities including but not limited to factory acceptance testing and site acceptance testing
•Evaluate validation protocol content and execution
Basic Qualifications
•University degree. Engineering or Science related discipline preferred
•Significant experience (10yrs +) working in the pharmaceutical or biotechnology industry
Preferred Qualifications
•Excellent written and verbal communication skills
•Experience working with dynamic cross-functional teams and influencing decisions
•Knowledge of applicable Regulatory requirements
•Experience with Regulatory inspections
•Operational Excellence experience