PE Global is currently recruiting a Compliance Specialist for a 12-month contract, with a leading multi-national Pharmaceutical client based in Limerick.
This is initially a 12-month contract position, fully onsite, offering a lucrative hourly rate.
Duties of the role/Responsibilities
- Completes investigations of technical deviations for department issues of noncompliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
- Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance
- Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies and
- Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures.
- Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as
- Continuous Improvement
Education/Experience
- BS/BA in Engineering, Chemistry or Sciences
- 2+ years of related experience within a cGMP environment
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU
- Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
- Strong interpersonal, presentation, communication and investigation skills with the ability to engage with a diverse range of individuals across all levels of the
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up-to-date CV to chloe.slingsby@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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