Cache of job #13818228

Job Title

Senior QC Specialist

Employer

Pe Global

Location

Cork

Description

Responsibilities of the role: Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality objectives are met. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs. Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products. Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May assist with compliance audits as required. Interfaces with contract manufacturers to address documentation and compliance issues. Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed. Normally receives no instruction on routine work, general instructions on new assignments. Education and Experience required: Degree in Science or equivalent. Experience in the Pharmaceutical Industry is required. QC background is essential. Proficiency in application of QA principles, concepts, industry practices, and standards. Knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations. This job originally appeared on RecruitIreland.com.

Date Added

2353 days ago

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