Operate as part of the QC team according to Company safety policies and cGMP to drive compliance with Global policies, procedures, guidelines and regulatory requirements in the performance of all applicable job functions.
Complete all documentation in compliance with cGMP and GxP standards.
Perform receipt and release of all materials ensuring QC Right First Time and turnaround time KPIs are achieved.
Review of all vendor and external laboratory documentation associated with receipt and release of materials to ensure compliance with internal specifications and Pharmacopeia.
Maintain clear, accurate records associated with all day-to-day activities.
Demonstrate proficiency in job related computer applications e.g., SAP, LIM\xe2\x80\x99s
Demonstrate ability to navigate, understand and comply to company test specifications and Pharmacopeia.
Facilitate and drive effective communication to ensure success. Liaise effectively with external groups to ensure progress of material receipt and release. Collaborating with others by sharing your skill set and expertise.
Support and participation in Internal Investigations
Ensure that all Quality Systems within the department are adhered to on a daily basis.
Problem solving to get to root cause of issues.
Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections.
Current Employees apply
Current Contingent Workers apply
Secondary Language(s) :
\xe2\x80\x988 - 13 years\xe2\x80\x99 experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
Degree in Science, Engineering or similar
Good communication, interpersonal skills and ability to work across teams.
Proven organizational skills and excellent attention to detail
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Proficiency in Microsoft Office and job-related computer applications required e.g., SAP, LIM\xe2\x80\x99s
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
Demonstrated ability to drive the completion of tasks.
Proven decision-making capability with accountability and responsibility.
Demonstrated ability to solve problems.
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