A leading pharmaceuticals business based in South Dublin are looking to hire a Qualified Person to support the batch release process of biologics products that are developed and manufactured on-site.
This role would be a great step for either an experienced non-sterile QP who is looking to gain experience in biologics, or a more junior eligible QP with a sterile/biologics batch release support background who is looking to step up into a traditional QP role.
As Qualified Person you will be an active member of the Quality Assurance batch release team and be the subject matter expert for your area that will span a broad range of projects, processes, and drug products. You would hold specific oversight and responsibilities for key quality systems and processes and will also serve as a primary quality partner for other key functional areas. You will also support with project specific activity, including continuous improvement and operational excellence initiatives.
As Qualified Person, you will be responsible for:
- Final disposition and certification to ensure that the batch has been manufactured in accordance with the requirements of the Marketing Authorisation and guidelines of cGMP.
- Providing overall quality direction and oversight for key functional areas such as Process Development, Validation, Quality Control, Supply Chain and Engineering.
- Coordinating and approving Product Quality Reviews including batch listing and deviation trend reports.
- Quality SME review and approval for regulatory submissions to ensure compliance with site and corporate procedures.
- Quality Risk Management
- Provision of QA Subject Matter Expertise for complex investigations and associated CAPAs, as required
- Inspection readiness activities and hosting of internal and external audits/inspections
- Participation in self-inspection program in a lead auditor or auditor capacity
- Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums
- Provision of Quality Oversight and partnership for internal and external customers
- Assuming site or business process owner roles and active participation at network meetings and external forums
You will have the following experience:
- Must satisfy the minimum requirements as outlined in Directive 2001/83/EC to act as a Qualified Person
- Acquired technical skills and demonstrated competencies across a broad range of quality related disciplines.
- Relevant experience working in the pharmaceutical or biotechnology industry in Quality Assurance
- Educated to degree level in a Scientific or related discipline
A salary of €80,000 - €90,000 is on offer dependent on the level of prior experience with an excellent benefits package and flexible working.
This role represents a great opportunity to grow at 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.
If you have any questions prior to applying, then you can also contact James Ivall at Goodman Masson to discuss further. We look forward to hearing from you.