15960948-QC NPI Project Specialist-Athlone Contractor

This is a 6-month contract.

Purpose:

This position is responsible for actively managing new product introductions within Athlone QC. In this role, you should have excellent relationship-building and problem-solving skills. High attention to detail and excellent verbal and written communication skills are vital to success in the role.

Responsibilities:

• Develop a project plan for all QC activities required to support new product introduction and track adherence to plan as per the project timelines
• Represent the QC department and actively participate in cross-functional meetings for NPI projects acting as SME as required
• Identify, lead and implement changes required to support the successful introduction of new products to the QC lab following site change management procedures
• Lead the introduction of new methods/techniques/technologies into the QC Microbiology laboratory i.e. QC method validation/co-validation of in-process methods required for NPI e.g. HPLC, SoloVPE, Bioburden, Endotoxin
• Support the generation, review, and approval of data and associated method validation/verification reports
• Assess and document testing requirements for new materials required for manufacturing
• Responsible for QC review and approval of documents required for NPI including hold time study protocols, technical assessments, material specification reports, and summary reports
• Support QC data review and approval of data generated to support NPI
• Support investigation of major laboratory investigations related to NPI, identifying and implementing robust CAPAs to prevent a recurrence
• Develop simplified and effective scheduling for NPI activities to maximize available resources and coordinate testing of NPI product/study samples with the QC lab team
• Present and report on project progress to QC management on a regular basis and maintain regular and proactive communication with all stakeholders.
• Coordinate and oversee sample submission to external labs for NPI
• Support the introduction and qualification of new QC equipment as required for NPI

Minimum Qualifications & Requirements:

• At least 5 years working in a GMP Quality Control / Quality Assurance role
• BSc./MSc. Degree in science/pharmaceutical-related subject
• Knowledge and understanding of GMP/GDP standards
• Strong problem solving and leadership experience
• Experienced in leading and executing projects
• Experience in method validation
• Highly Computer literate, with MS Office (Word, Excel)
• Good working knowledge of QC Microbiology and Chemistry instrumentation and methods is beneficial
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Excellent communication & presentation skills are essential.
• Excellent time management organizational skills along with a proven ability to multi-task.