Pharmaceutical & Biotechnology

Senior QA Specialist – External Manufacturing

Posted 3 days ago
Contract
South Dublin, County Dublin, Ireland
42057560

Desired Skills: quality assurance,external manufacturing,CMO

The role:

PE Global is currently recruiting for a Sr QA Specialist – External Manufacturing on behalf of a leading biotech company in Dublin South. This is an initial 18 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.

Education and Experience:

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

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

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

Associate’s degree and 10 years of Quality and/or Manufacturing experience
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 MS Word; MS Excel; MS PowerPoint; MS Visio; MS Project, Trackwise
Demonstrated ability to deliver results through living the values.
Negotiation skills when working with external suppliers and internal team members
Ability to maintain remote working relationships with colleagues at other sites.