Job Title: QA Specialist
Location: Cork
Summary:
My client a world leading pharma company are looking to recruit 2 Quality Assurance Specialist to join their team for a 12 months contract. The role will be largely involved in Packaging & Engineering.

Responsibilities:

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through quality support of Packaging and Engineering functions.
Works directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Performs QA Review and approval on routine Packaging and Engineering documents including tech trial protocols and reports.
Supports development of solutions to more complex problems, identifies deviations from accepted practice and evaluates impact assessment as required.
Involvement in investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and packaging.
May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
May assist with compliance audits as required.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
May participate in QA review and approval of artwork and product master data.
Involvement with secondary packaging contract organisation, performing QA review and approval of associated documents, i.e. complaints, packaging instructions, change controls.
Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
Normally receives no instruction on routine work, general instructions on new assignments.

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