QA Manufacturing Specialist

Desired Skills: manufacturing,quality,operations

The Role:

PE Global are recruiting for a QA Manufacturing Specialist/Manufacturing Manager to be based in Dun Laoghaire

12 Month initial contract , hybrid predominately remote with max two days per week on site

• There is approx. 5% of travel involved in the role. The travel covers Italy, Germany, Switzerland, England, or Scotland. These will be short trips and will spend day and a half. This wouldn’t exceed two and a half days.

Preferred Profile:

• There is a strong preference to have somebody from a manufacturing (facilities) background. We’d love to see someone who’s worked at an internal site somewhere.
• Quality or Operations experience / background can also be considered for the role (both would work in this role)
• Strike relationships, and strong decision making (strong influence) as operations have to drive pillars as they have to work through process development, supply chain, and quality, and the CW need to be able to drive these areas.
• Would love to have someone who’s already worked with aseptic filling, or tech transfer drug packaging experience – if possible (not essential)

Job Description:

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

Preferred Qualifications:

• 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.
• Able to defend processes, procedures, and decisions during regulatory inspections.
• Organizational savvy and presence to build effective relationships across functions.
• Excellent interpersonal relationship skills.
• 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
• Demonstrated ability to deliver results through living values.
• Negotiation skills when working with external suppliers and internal team members
• Ability to maintain remote working relationships with colleagues at other sites.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey Mccarthy on +353 21 4297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net