Site Name: Ireland - Dublin
Posted Date: Mar 5 2025
We have a new opportunity for an IMP Qualified Person to join our team on a permanent basis at Citywest Dublin. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials - Regulation (EU) No. 536/2014, article 4 of Delegated Regulation 1569/2017, Article 51 of Directive 2001/83/EC dependant on location.
In this role you will also interact with GSK external partners and collaborators.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a 50 % hybrid working model, empowering you to find the optimal balance between remote and in-office work.
In this role you will…
* Provide Qualified Person certification as defined in EU directive 2001/20/EC, regulation 536/2014, Article 51 of Directive 2001/83/EC and perform QP release of a range of Investigational medicinal products.
* Ensure a compliant operation is in place to allow for EU certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements and that they conform to regulatory submissions.
* Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
* Provide QP advice and consultancy working with GSK project teams, external collaboration partners and external sponsors to reduce regulatory risk to GSK and ensure information and other QP assurances are obtained (as required).
* Build and maintain effective internal GSK and External business relationships. Working with the senior EUQP’s, develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D including coaching, mentoring, or training.
* Participate in routine or regulatory audits and investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
* Science degree and/or QP eligible equivalent degree and extensive experience in pharmaceutical manufacturing and quality operations.
* Eligible to act as Qualified Person in the EU (Ireland).
* Experience with the QP certification of major dose forms such as Tablets, aseptic sterile manufacture and biopharm products.
* Broad knowledge of quality management.
* Capable of leading, and working in multi-disciplinary teams based in different geographical locations to develop value added-solutions.
Preferred Qualifications/ Experience
If you have the following characteristics, it would be a plus:
* Previous experience of working with external partners.
* Experience in QP certification of Investigational Medicinal products.
* Experienced in Regulatory Health Authority Inspections.
* Proven track record of taking accountability of being able to make difficult (“grey area”) decisions, navigating the regulations, influencing stakeholders and escalating risks to senior management where appropriate.
Closing Date for Applications: 19th March 2025 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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