Job Description
Catalyx is seeking a QA Specialist to work on a 6-month contract at our customer site in Cork. The ideal candidate will have a relevant third-level qualification in a QA discipline and a minimum of 2-3 years of relevant industrial experience in a QA role, preferably in the pharmaceutical sector.
**Job Summary:**
We are looking for a highly skilled QA Specialist to join our team. The successful candidate will be responsible for delivering Quality Assurance support to the Packaging Department, evaluating and approving GxP documentation, and conducting Batch Record Review and Batch Disposition processes.
**Responsibilities and Duties:**
- Deliver Quality Assurance support to the Packaging Department
- Evaluate and approve GxP documentation
- Conduct Batch Record Review and Batch Disposition processes
- Update Quality Assurance Standard Operating Procedures (SOPs) as necessary
- Scan and archive documents as needed
- Inspect finished products
- Perform investigations into deviations and conduct Root Cause Analysis
- Generate reports for customer complaints
- Conduct line clearance for packaging areas
- Suggest process enhancements and recommend changes
- Assist with internal and regulatory audits/inspections as required
- Support the training and mentoring of new employees
- Provide additional support and assistance on tasks and projects as directed by management
- Collaborate with cross-functional teams
- Achieve agreed-upon KPIs and metrics
**Qualifications and Experience:**
- 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
**Why Catalyx?**
We take care of our people and offer a Total Rewards package that includes great personal benefits and professional growth opportunities.