Cpl are currently recruiting for a Lead Auditor to work with a world leading pharmaceutical company in Co. Kildare.
About Our Client
Situated in Co. Kildare, our client is one of Europe's leading manufacturers of solid dose pharmaceuticals. They manufacture tablets and capsules for global markets using highly complex processes and we are investing in and regenerating our business for the future.
If you enjoy working in a dynamic environment with a chance to grow, develop and get involved in exciting, challenging, and diverse opportunities we would like to hear from you.
What you will do:
The role requires a dynamic self-starter who will assume responsibility for the Internal GMP Audit programme.
You will work with the team leader to design and develop the internal audit plan and will have a key role in leading the execution of the internal audit programme and will work with colleagues across the site as part of a cross functional auditing team.
Your role will be to build upon and improve existing GMP Auditing programmes, act as a subject matter expert for GMP auditing, train and coach others on auditing skills, support auditors and auditees to ensure robust impact assessment, root cause analysis and effective CAPA planning. The role has primary responsibility for audit execution and support during site inspections, while also performing other QA duties as part of the wider Quality Systems & Compliance team.
The ideal candidate will be curious, highly motivated, and passionate about demonstrating and delivering excellence, auditing, and continuous improvement. Strong judgment, critical thinking, attention to detail, organisation and influencing skills in working with different stakeholders will be required.
- Lead internal GMP audit teams
- Working in partnership with Compliance Leads across other functional areas, building capability in auditing.
- Drive standardization of ways of working, and simplification of business process to deliver compliance while creating space for other meaningful work.
- Influencing continuous compliance improvement in line with cGMP, client standards and inputs from site system trends.
- Perform focused assessment or special assignments to target GMP continuous improvements
- Ensure cGMP compliance and being audit ready at all times
- Lead cross-functional groups in order to troubleshoot any issues and to identify preventative actions
Engagement and Strategy
- Participate in our client’s Network programs, to ensure 2-way best practice sharing
- Engaging with auditing peers in other functions and sites to ensure an effective audit programme
To be successful in this role you will require:
- Third level qualification in a science or technical field (exceptions may be considered)
- Lead Auditor qualification
- Possess exceptional critical thinking, investigation, and forensic data analysis skills with the ability to navigate and resolve complex systems/issues
- Excellent working knowledge in auditing, GMP standards and regulations
- Strong written and oral communication skills, report writing and editorial skills.
- An ability to work in a dynamic, fast-paced and goal driven environment
- Minimum of 3 years’ experience in the pharmaceutical industry in Quality Assurance including extensive auditing experience (exceptions may be considered).
All applicants must have the relevant authorisation to live and work in Ireland.