Sampling Booth Project Lead Shannon, Co Clare 6-month contract Key Responsibilities: Project Management: Oversee and manage the full operational scope of the Sampling Booth for ID testing of raw materials, ensuring timely delivery, compliance, and quality standards.
Process Design & Development: Lead the design and implementation of processes for the use of the Sampling Booth, ensuring it aligns with industry best practices for material sampling and testing.
Testing Strategy Development: Develop and implement a comprehensive release testing strategy following sampling, including management of shelf life, storage, and sample integrity.
SOP Creation: Define, design, and write Standard Operating Procedures (SOPs) for Sampling Booth operations, such as material movement, gowning protocols, materials preparation, sampling management, labeling, sample storage, and CNC cleaning maintenance.
Validation & Commissioning: Oversee the validation and commissioning of the Sampling Booth and related equipment.
Author and manage the creation of all required validation documentation, such as URS (User Requirement Specification), SIA (System Impact Assessment), GAMP (Good Automated Manufacturing Practice), Validation Plans, IQ (Installation Qualification), OQ (Operational Qualification), and RTM (Requirements Traceability Matrix).
Raman Testing Integration: Manage the integration of the Raman spectrometry system for ID testing in conjunction with the Sampling Booth, ensuring proper operational compatibility.
Qualifications & Experience: Bachelor's degree in a relevant field (e.g., Engineering, Chemistry, Quality Assurance).
Proven experience in project management, particularly in the life sciences, pharmaceutical, or manufacturing industries.
Strong knowledge of regulatory requirements, validation processes, and SOP development.
Expertise in material sampling, process design, and laboratory testing systems.
Familiarity with Raman spectroscopy or similar analytical methods is a plus.
Exceptional communication, problem-solving, and organizational skills.
Please contact me for a confidential discussion or to discuss further.
Deirdre Sheehan Skills: Validation Design Project Management Benefits: Mobile phone Paid Holidays Canteen Parking Pension Laptop Life Assurance