Overview
PE Global is currently recruiting for a QC Analyst for a leading multi-national Pharma client based in Carlow.
This is a contract position.
Responsibilities
As QC Analyst you will perform and review a range of techniques such as immunoassays, cell based potency bioassays HPLC and compendial methods as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release. Reporting to the QC Manager you will ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and reliable supply to our customers.
Our QC group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Responsibilities:
Work as directed by the QC Manager / Associate Director, according to Company safety policies, cGMP and cGLP.
Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
Ensure that all Quality Systems within the department are adhered to on a daily basis.
Operate as part of the QC team performing the allocated testing and laboratory-based duties.
Ensure timely completion of all assigned data processing and reviewing.
Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures
Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
Requirements
Bachelor’s Degree or higher preferred; ideally in a science related discipline.
Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
Knowledge of cGMP
Laboratory Quality Systems
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@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***
#J-18808-Ljbffr