Job Description
A QA Specialist is required on an initial basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company.
This role involves performing various activities to ensure compliance with applicable cGxP regulatory requirements, including developing Standard Operating Procedures, reviewing and approving controlled documents, and identifying deviations from accepted practices.
* Ensures quality objectives are met through the development and implementation of SOPs and controlled documents.
* Reviews and approves SOPs and other types of controlled documents to ensure compliance.
* Performs QA review and release of primary and secondary packaging components, artwork, and GMP Deviation investigations and CAPAs.
* Reviews and approves Master data and recipes required for operations, and assists with compliance audits and walkthroughs as required.
* Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).
Requirements:
* Prior experience in the pharmaceutical industry, preferably within a QA role.
* Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs) and FDA/EMEA standards and quality systems.
* Proficiency in application of QA principles, concepts, industry practices, and standards.
* Demonstrates basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.
* Good verbal, technical writing, and interpersonal skills, and proficiency in Microsoft Office applications.
The successful candidate will be required to exercise judgment within well-defined procedures and practices to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
Key Responsibilities
* Participate in developing SOPs and controlled documents to ensure quality objectives are met.
* Review and approve SOPs and other types of controlled documents.
* Perform QA review and release of primary and secondary packaging components, artwork, and GMP Deviation investigations and CAPAs.
* Review and approve Master data and recipes required for operations.
* Assist with compliance audits and walkthroughs as required.
* Maintain programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).