SEDA Talent
The Client
My client is a pharmaceutical manufacturer. They have been a market leader in their industry for over 30 years with a first class manufacturing suite.
We are currently recruiting a Qualified Person to join their senior team on a hybrid basis.
The Role
- Ensuring that an effective pharmaceutical Quality Management system is operated and that all regulatory obligations of the manufacturing authorisation holder are fulfilled
- Being responsible for disposition of medicinal veterinary product
- Manage communications with and represent the company during Regulatory Inspection.
- Support Regulatory inspections and prepare written responses to inspections.
- Prepare and approve Regulatory variations.
- Support internal compliance audits of operations.
- Oversee the team in the review and approval of Non-Conformances (NC), CAPA, change controls and complaints.
- Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
- Assist in the preparation, review and regular update of technical agreements with licensees and 3rd party contractors.
- Organise and schedule periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
- Participating in cross functional teams as Qualified Person representative
- Providing advice and direction to other company departments on quality and regulatory issues
- Apply high ethical standards and professional conduct with clients and with Authorities
The Person
- Experience in sterile manufacturing at an MIA site
- A relevant third level qualification in Science or equivalent
- The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 91/412/EEC , EU2019/6 & Annex 16.
Next Steps
To apply for this position please click the link to send your CV, or call Seamus at SEDA Talent on 00353 576 9941 for more details.
