Page 12 - KEY PROJECT JOBS BOOKLET 14th MAY 2020

Quality, Regulatory & Validation Role for Pharma Manufacturing and
Distribution

Employer: FQS Ltd
Location: Waterford
Core Skills and Specifications:
· Minimum degree level education with 2+ years industry experience.
Sector or industry experience in planning scheduling, executing and leading various
Quality Management System (QMS) projects/ assignments is essential.
Must be well organised with excellent oral and written skills.
Experience in design and implementation of quality systems for GMP and GDP.
Able team player with strong issue resolution and communication skills across
functions and organisations.
An ability to work flexibly, upon their own initiate in a changing environment.
Excellent attention to detail and priority management essential.
Open to learning new skills and taking on new tasks and responsibilities.
The ability to work independently on complex Quality/regulatory/validation tasks.
Industry Quality Management System Auditing experience would be advantageous
but not essential.
Working knowledge and awareness of EU and US regulatory requirements
Qualified Person (QP) & Responsible Person (RP) is advantageous
Full driving licence & own car required.

How to apply https://ie.indeed.com/jobs?q&l=Waterford%20city%2C%20County%
20Waterford&sort=date&advn=6239158864320698&vjk=56524c78f9762b5c

Quality Specialist

Employer: BrightWater
Location: Waterford
Role
Participate in the preparation and review of procedures and batch documentation.
Review and approval of deviation, CAPA’s, quality events and tasks.
Ensure the quality system at Sis effectively implemented and maintained.
Acts as Quality Point person for systems / processes providing guidance / feedback
on quality issues.
Perform timely review of documentation / investigations / reports highlighting and
assisting in the resolution of concerns commensurate with the risk.
Work with relevant departments to ensure timely closure of quality actions /
findings.
Actively contribute to continuous improvement initiatives.
Conduct duties in a safe manner and report all safety issues or concerns.
Requirements
Bachelor’s degree in a science related subject is essential.
3 years’ experience in a manufacturing environment, sterile experience is preferable
Effective technical knowledge of sterile manufacturing processes
Operational experience of quality systems in a dynamic manufacturing environment
Knowledge of requirements for cGMP, US and EU regulatory requirements
Full understanding of relevant quality and compliance regulations
Able to manage projects to plan/budget

How to apply https://ie.indeed.com/jobs?q&l=Waterford%20city%2C%20County%
20Waterford&sort=date&vjk=97d8d530af08a9d2