Role Title: Qualified Person Duration: 8 months Location: Harlow Rate: £1000 per day – via Umbrella Inside IR35
Role purpose / summary
We have a new opportunity for a Qualified Person to join our team at Harlow, UK. 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 - Directive 2001/20/EC, Article 62(1) of Regulation (EU) No. 536/2014, article 4 of Delegated Regulation 1569/2017, Article 51 of Directive 2001/83/EC and Statutory Instrument 2004/1031 (43.(2)) dependant on location. You will also interact with external partners and collaborators.
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 UK equivalents and perform QP release of a range of bulk and primary packed Investigational medicinal products
- Ensure a compliant operation is in place to allow for UK 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 project teams, external collaboration partners and external sponsors to reduce regulatory risk to and ensure information and other QP assurances are obtained (as required).
- Build and maintain effective internal and External business relationships. communicate and interact at various levels internally and externally to. 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.
Key Skills/ requirements
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- Science degree and extensive experience in pharmaceutical manufacturing and quality operations.
- Eligible to act as Qualified Person in the UK
- Experience with the QP certification of major dose forms such as Tablets, aseptic sterile manufacture and biopharm products
- Experienced in Regulatory Inspections
- Broad knowledge of quality management
- Capable of working in multi-disciplinary teams
- Experience with Batch Review as a Qualified Person is mandatory for this position
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.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!