QC Specialist

The role:

PE Global is currently recruiting for a QC Support Specialist on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role.

Description:

• Responsible for generating and expediting review and approval processes for QC GMP documentation including but not limited to Quality Notifications, Laboratory Investigations, CAPAs, Effectiveness Checks, Standard Operating Procedures, Standard Work Instructions and change controls, Annual Product Reviews, Trend Reports, Out of Process Control Limit events, Compendial Assessments.
• Author/ Provide technical expertise and technical oversight of the above QC documentation.
• Ensure that objectives are effectively achieved, consistent with MSDs requirements to ensure compliance, safety, and reliable supply to our customers.

Responsibilities:

• Support Quality Control activities in the QO laboratory through documentation generation and investigations associated with GMP activities.
• Author/ Provide technical expertise and technical oversight of Investigations, Quality Notification, Out of Process Control Limit OOPCL completion,
• Be a document system expert; this will include document review, approval and document system work flow expedition.
• Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
• Documents will include SOP’s, SWI’s, training documents, and change controls.
• Support Laboratory activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
• Support Batch release through timely Investigations, Quality Notification, Out of Process Control Limit OOPCL completion, Interim/summary report generation; meeting batch release requirements.
• Perform Compendial Assessments.
• Author Annual Product Review, Trend Reports.
• Raise CAPA’s and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
• Required to comply with MSD Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP)

Education and Experience:

• Bachelor’s Degree or higher preferred; ideally in a Science, or other Technical discipline
• Relevant experience in QC Laboratory within GMP setting
• Proficiency in Microsoft Office and job-related computer applications required with proven analytical and systematic problem-solving skills
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills required
• Analytical Method validation

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@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***