A leading pharmaceuticals manufacturing business based in Cork are looking to hire a Qualified Person to support the batch release of a wide range of complex products manufactured on-site.
The position will be responsible for the release of a broad portfolio of products and will ensure compliance to new and established systems and global regulations whilst also driving QMS implementation and improvement. You will be based on a well-established site working with a highly skilled team so you will be well supported by a network of industry specialists in your role as QP.
This position would suit you best if you are looking for a step-up in your career to become a Qualified Person with a wider remit having previously acted in a Quality Assurance Specialist or similar role where you have supported the batch release process. You will be eligible to be nominated as a Qualified Person in Ireland.
As Qualified Person, you would have responsibility for:
- Inclusion on the Manufacturing License as a Qualified Person at an FDA / HPRA approved manufacturing facility
- Product release: you will ensure that each batch is manufactured in accordance with the current EU/FDA GMP Directives and the relevant marketing authorisation.
- Ensure compliance to new and established systems, global regulations and guidelines
- Lead and participate in validation activities
- Quality performance reporting, and support of investigations.
- Supporting the implementation of the site excellence program by leading and implementing improvements
- Supporting the development of new quality system procedures and processes
- Help drive Quality culture
- GMP and GDP compliance
You will have the following experience:
- QP Qualification
- Degree in technical or science-related discipline
- Ideally 2-3 years in a QA Specialist or Compliance Role with previous experience in a batch release type role in a pharmaceutical GMP/GDP environment
A salary of €65,000 - €75,000 is on offer dependent on the level of prior experience with an excellent benefits package.
This role represents a great opportunity to grow as a QP for a global pharmaceuticals business with industry leading training to develop your skill set.
This position is a critical hire to support business growth so interviews will be held within the next 2 weeks ideally. If you are considering a move and this looks like it could right next step, then please apply as soon as possible to be considered for interview.
You can also contact James Ivall at Goodman Masson on +44 2073 240 538 to discuss further.