Quality Assurance Specialist Job Overview
Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations to empower them to enhance efficiency and drive success.
Job Description:
The Quality Assurance Specialist will be responsible for delivering Quality Assurance support to the Packaging Department. This includes evaluating and approving GxP documentation, conducting Batch Record Review and Batch Disposition processes, updating Quality Assurance Standard Operating Procedures (SOPs) as necessary, scanning and archiving documents as needed, inspecting finished products, performing investigations into deviations and conducting Root Cause Analysis, generating reports for customer complaints, conducting line clearance for packaging areas, suggesting process enhancements and recommending changes, assisting with internal and regulatory audits/inspections as required, supporting the training and mentoring of new employees, providing additional support and assistance on tasks and projects as directed by management, collaborating with cross-functional teams, and achieving agreed-upon KPIs and metrics.
Required Skills and Qualifications:
* A relevant third-level qualification in a QA discipline.
* A minimum of 2-3 years of relevant industrial experience in a QA role, preferably in the pharmaceutical sector.
* Experience with Batch Record Review in Pharma/Med Devices is essential.
* Demonstrable understanding of Document Control principles, Quality Systems, and GMP requirements.
* Comprehensive knowledge of document control processes and the relationship between document change processes and products.
* Familiarity with the current pharmaceutical industry and relevant regulations, including 21 CFR, GxP, and ICH guidelines.
* Proficiency with Electronic Document Management Systems (EDMS).
* Stay informed about compliance requirements in your work area.
* Exhibit strong problem-solving skills with attention to detail.
* Proficiency in Microsoft Office applications and experience with Oracle.
* Excellent written and verbal communication skills, coupled with strong interpersonal skills.
* A proactive attitude toward customer service and performance.
Key Requirements:
We are seeking a motivated and skilled Quality Assurance Specialist who can excel in this dynamic role. If you possess the skills and qualifications outlined below, we encourage you to apply.
How To Apply:
Apply now if you have the right mix of skills, qualifications, and passion for quality assurance. We look forward to hearing from you.