Quality Systems Specialist 37176J


Category: Pharmaceutical / Science
Job Type: Contract

Posted on:
Last Updated:

JobTitle Quality Systems Specialist 37176J

About Company Our client based in Limerick is seeking a Quality Systems Specialist to join its expanding team.

Duration of Role 12 Months

Summary Objective This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements.

Job Duties 

• Drives compliant execution of the following for their assigned processes and projects

• Manages specified quality system processes

• Works directly with various customers of the quality system processes to ensure compliance to site, sector/franchise/regulatory requirements

• Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner

• Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards

• Understand and uses data, key metrics and statistical methods, quality tools or computer based solutions to improve processes

• Responsible for identifying and communicating the need for process improvement opportunities to responsible management

• Identifies personnel that require training on the relevant processes and rolls out training as required

• Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus in simplifying and standardizing processes. Lead and drive improvements as required

• Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc

• Support the assigned processes during internal and external audits

• Conducts internal audits to ensure compliance to regulatory and customer requirements

Requirements
no visa processing

• At a minimum a Diploma in a Quality, Science or Engineering discipline 3 or more years of related experience

• Desirable a Degree in a Quality, Science or Engineering discipline with 5 or more years of related experience

• Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems

• Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met

• Demonstrate excellent communication skills (verbal and written) with all levels within the organization, clients and regulatory auditors

• Must show innovative development techniques and strategic thinking abilities

• Demonstrated success in managing multiple projects

Benefits
Benefits of working with Independent Solutions

Benefit from Independent Solutions ethical principles!

We look after our team, we know the business, we have been working in the sector >20 years.  We are not a recruitment agency

While placed on client sites you will be an integral part of our team, gaining support and  access to the knowledge and experience of our cross functional LifeScience team

We offer attractive rates – competitive margins compared to our competitors.

Payment on time and in full

We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects

We work for you !

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