Quality Person Lead
Qualified Person Lead
Reporting To: Quality Director, EU Sites
Very attractive salary & benefit package
Main purpose of job:
This role is a Senior QP role and will take a lead role in our clients QP oversight, advising QP's on site and being a point of escalation for the QP group.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Maintain compliance with GMP and customer expectations as defined in Quality Agreements, HPRA/Ireland legal framework, HPRA licences and EU GMP Directives/Guidelines.
- Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
- Support the sites clinical and commercial activities including Third Party release.
- Review Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
- Review Batch Documents for all operations performed.
- Certify Medicinal Products for use in the EU and outside the EU (where relevant).
- Undertake audits in EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
- Provide advice and guidance to staff and Customers regarding QP requirements within the EU.
- Keep up to date with the requirements of the national regulatory authorities across the EU and rest of world (where relevant).
- Review company Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and company procedures.
- Provide input and assistance with relevant elements of the Quality Management System (QMS).
- Assist with regulatory inspections and client audits.
- Agree and work towards achievement of personal development goals.
- Where required, undertake departmental tasks and projects outside the job holder's area of responsibility in line with departmental and senior management team objectives.
- Identify and support opportunities for improving internal processes and or procedures
- Support training needs across the site for Commercial and Clinical Activities.
If you meet the above criteria and are interested in this role, please apply now