QA Manager

Description:

PE Global is currently recruiting for an QA Manager on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

Responsibilities:

• Position will be responsible for managing and executing total quality management systems for the External Supply organization (Raw Materials Categories, Devices, and Contract Manufacturing)
• Position is expected to execute nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities. Act as the category owner for all quality records and procedures.
• The Specialist processes, investigates and acts as first responders to deviations.
• Addresses and expedites product deviation under the company’s quality management system procedures, and ensures compliance with regulatory agencies.
• Monitors, investigates deviations and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses.
• Maintains unified product defect investigation operating procedures.
• Provides technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent reoccurring events.
• Maintains and monitors systems to ensure that all deviations received are appropriately investigated and concluded per the company’s quality standards and procedures.
• Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.
• May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.
• May assist in the development of work force model criteria to support business initiatives for the department needs.

Basic Qualifications:

• Doctorate degree and 2 years of Quality and/or Manufacturing experience

OR

• Master’s degree and 6 years of Quality and/or Manufacturing experience

OR

• Bachelor’s degree and 8 years of Quality and/or Manufacturing experience

OR

• Associate’s degree and 10 years of Quality and/or Manufacturing experience

OR

• High school diploma / GED and 12 years Quality and/or Manufacturing experience

Experience Requirements:

• 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
• Understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
• Thorough working knowledge of EU and US cGMPs regulations
• Demonstrated ability to work with minimal supervision, present data in an organized and logical manner, and communicate effectively
• Demonstrated ability to coordinate and lead cross-functional project teams and deliver on schedule.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Excellent Technical Oral and written skills, ability to write/evaluate investigation responses to comply to regulatory requirements
• General understanding of Operational Excellence skills with emphasis on Root Cause Analysis
• Proficient with MSWord; MSExcel; MSPowerPoint; MSVisio; MSProject, Trackwise

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***