The role:
PE Global is currently recruiting for a QA Inspection Readiness Specialist on behalf of our client based in Meath.
This is an initial 11-month contract role.
There are two positions open and they will be Hybrid working model.
This role requires a seasoned QA Specialist with a minimum of 4 years’ experience in a similar related role in the Biopharmaceutical industry. A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant GMPs, regulations and current industry trends
Role Functions
(Functions include, but are not limited to, the following)
- Support the implementation of the Inspection Readiness activities on-site.
- Support Compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as applicable Regulatory Requirements.
- Lead proactive evaluation of site compliance against emerging regulatory trends.
- Be an advocate of continuous improvement in the Quality Management Systems.
- Support internal audits (facility, system and walkthrough) in addition to supporting management of the internal audit schedule at the site.
- Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.
- Generate and report metrics / trends for program adherence to requirements and effectiveness.
Experience, Knowledge & Skills & Qualifications
- At least 2 years’ experience in supporting Inspection Readiness Programs/ Internal Audit programs in a pharma/biotech regulated environment. Experience working in a drug substance manufacturing environment is highly desirable.
- The motivation to be an inspiring member of a high performing team.
- Communication, decision making, people influencing, and project management skills will be important.
- Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- GMP Inspection Readiness & Audit experience in the pharmaceutical industry
- Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues
- The desire to continuously learn, improve and develop
Education
- Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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