Qualified Person (Qp) - New Product Introduction (Npi)

Site Name: UK - Hertfordshire - Ware Posted Date: Oct 28 2024 The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites.
The team supervises all quality related systems, improvement procedures and documentation (including data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets).
Job Purpose: The Qualified Person (QP) reviews and certifies finished products (batches) for release/onward progression (to market).
QPs are responsible for ensuring that batches are manufactured in compliance with laws (for all the Member State where certification takes place) and in accordance with the requirements of marketing authorization (MA).
All released products must conform to required quality standards (by reviewing appropriate documentation) and have been manufactured and packaged according to the regulatory dossier, Good Manufacturing Practice (GMP) and business requirements.
This role is directly aligned to New Production Introductions (NPIs) to oversee the introduction of new products to the Ware site and act as an interface with GSK Research and Development (R&D).
In delivery you will oversee compliance with clinical trial legislation and liaise with R&D colleagues (as well as other key stakeholders) in support of development, transfer and launch of new products from GSK manufacturing site at Ware (Hertfordshire).
In delivering the role, the QP takes informed decisions on the suitability of products to be released (for both IMP and commercial batches as applicable).
Key responsibilities (include): Approval of batch certificates and API certificates.
Completion of continuous professional development to include training regarding the product type, production processes, technical advances and changes to regulations and GMP.
This extends to maintaining knowledge of regulatory status for product licenses as well as respective variations (in terms of aligned product types).
Coaching and support to departmental staff and value stream in terms of quality expectations to include (via Gemba's and process confirmations, as well as presence in the production facility).
This extends to providing governance to departmental and stream compliance, quality systems and processes.
Direct support to deviations (including provision of coaching/guidance) and oversight (and approval) to QMS processes and documents (as appropriate).
Support to and lead where appropriate to the monitoring and continuous improvement activities.
Review and approval of Annual Quality Reviews.
Ensure inspection readiness for both own and supported areas and involvement (in L1-L4 inspections).
Provide quality support to aligned projects to ensure the correct quality strategy and change management is incorporated and delivered.
About You: You will be a Qualified Person (QP) - this is key to delivery in this role.
Your QP qualification must be recognized in the UK.
As this role is multi-faceted and collaborates with a wide variety of on-site production and operations teams, you will also be self-motivated with strong experience of working in quality at a sophisticated manufacturing site.
You will be resilient and calm, with strong communication skills.
Please Note: The role is a site-based role.
About Ware Manufacturing Site: Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form, and the site has circa 1,500 highly-motivated and capable people working at it.
The Ware site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in oral and solid dose forms, as well as operating a high-volume commercial production for respiratory devices.
CLOSING DATE for applications: Monday 11th of November 2024 (COB).
Basic Qualifications: Qualified Person (QP) stated on a current UK Manufacturer's/Importer's licence Relevant experience Benefits: GSK offers a range of benefits to its employees, which include, but are not limited to: Competitive base Salary Annual bonus based on company performance Opportunities to partake in on the job training courses Opportunities to attend and partake in industry conferences Opportunities for support for professional development/chartership Access to healthcare and wellbeing programmes Employee recognition programmes If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK .
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