We're looking to hire a QA professional to join our clients team. Your role will be to support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. You will be working within a team to ensure the quality of products will meet company standards.
Key Responsibilities
- Supporting and leading daily on cross functional teams to aid with compliance issues and achieve project milestones.
- Investigations and risk assessments in regards to deviations, complaints and changes are addressed and dealt with in a timely manner.
- Providing QA oversight for validation in Deviations, CAPAs/ SOPS, Change Controls as well as similar documentation in relation to GMP and site regulations.
- Providing QA knowledge into Tech transfers and regulatory approvals as well as quality / validation operations at the facility.
- Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
- Creating and maintaining SOPs and QA documentation in line with site requirements.
- Participate in and support risk management activities with relative insight and good practice.
- Participating in audits and cross-functional teams to ensure the best performance.
- Driving continuous improvement and working within a team to build strong relationships with management as well as colleagues.
- Escalating compliance risks as needed and delivering training while supporting enhancements to our Quality System
Skills, Attributes & Experience
- Bachelor's or Masters degree in Engineering, Science or related discipline.
- Minimum of 4+ years experience working in QA in a cGMP manufacturing environment and a deep understanding of regulatory requirements.
- Strong communication skills, both written and verbal
- Proactive, logical thinker with the ability to perform well under pressure.
- Team player who can also work independently
- High attention to detail in reviewing GMP documentation
- Experience with quality systems (e.g., Veeva, SAP, PAS-X)
- Knowledge of FDA, HPRA, EMEA, and other regulatory requirements
- Experience supporting regulatory inspections and agency interactions