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14 Jun 2023
About the Company
Opportunity for an experienced QC professional to lead a QC Team at a new Pharmaceutical site in Tipperary.
About the Position
In this role you will lead the QC team and lab. This fast paced and varied role encompasses laboratory testing across a range of applications along with documenting and reporting of test results in a timely manner. Exceptional attention to detail and a drive for efficiency will be required, with a consistent and accurate approach to testing and documentation whilst adhering to all aspects of company and industry cGMPs. This role is a central part of the QC laboratory operation and supports the wider compliance and quality teams with a common goal for continuous improvement and achieving the company’s business strategy aligned with our vision, mission and values.
Oversees the chemical analysis and quality issues of raw materials, packaging components, in-process, finished product and stability samples and ensures that testing results provide the highest quality support for manufacturing in compliance to cGMP, SOPs and quality standards.
Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and escalates related issues to Site Director of Quality in a timely manner.
Participate directly in and support all relevant regulatory and customer inspections including the provision and maintenance of adequate records, processes and documentation for inspection.
Collaborates with the internal departments on a regular basis to gain oversight on the weekly manufacturing production / final release product planning and assists in the creation of the test schedule for the QC team.
Supervision of lab personnel through the provision of clear objectives, positive employee environment, effective team working and adequate support to ensure their successful and effectively delivery of excellent customer service to all relevant stakeholders
Develop and maintain quality systems within the laboratory to ensure ongoing compliance with cGLP.
Development and updating of SOPs, validation protocols, validation reports and method validation / verifications and equipment qualifications.
Ensure timely completion of laboratory investigation, deviations, change controls and environmental out of specification results.
Bachelor’s Degree within a Scientific Discipline essential
Minimum 10 years’ experience in GMP environment within a pharmaceutical (HPLC) environment.
Minimum 5 years’ experience in a leadership role.
Strong analytical/quantitative skills
Excellent technical writing skills
Good understanding of root cause analysis and its application
Good computer skills with high proficiency in Microsoft Office a plus
Thorough understanding of quality systems and cGMPs.
Salary is negotiable depending on experience.
For more information on the role or any other Engineering or Life Sciences roles call
on 087 3618142 or
or click the apply button below.
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