Qualified Person
- Harlow, England (GBR)
- £1000 - £1100 Per Day
- 8 Months
- Start date: ASAP
- Ref: gsk-23618
- qualified person
- regulatory submissions
- quality management
- biopharm
- pharmaceutical manufacturing
- pharma
- audits
- inspections
- clinical trials
- customer complaints
Role Title: Qualified Person
Duration: 8 months
Location: GSK Harlow
Rate: £1000 per day – via Umbrella Inside IR35
Who Are We - GSK?
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc, although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. Our values and expectations are at the heart of everything we do and form an important part of our culture:
• Our values are Patient focus, Transparency, Respect, Integrity
• Our expectations are Courage, Accountability, Development, Teamwork
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 GSK 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 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. communicate and interact at various levels internally and externally to GSK. 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!
Join GSK’s vision to do more, feel better and live longer:
https://www.youtube.com/user/gskvision/
Who will I be working with?
http://www.gsk.com/en-gb/careers/meet-our-people/
