Qualified Person

Job Description

OverviewQP - Qualified Person If you are a QP you are probably quite comfortable in your current role - so why changeHave you ever been part of something truly special This is a unique opportunity to be part of an exciting period of growth for a company who will change the landscape of central Scotland for Scientists to develop and be part of something amazing! But they need you! And in return offer a very attractive Salary and benefits package The ideal Qualified Person would be someone possessing relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment.The biggest changes in life start with a simple step.apply now! Role responsibilities

• To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and described in Annex16 of the EU Guide to GMP
• To represent the company to external authorities on liaison with MHRA, FDA, EMEA CAs and OMCLs on; product defect reporting, recall and Inspection related matters (all interactions must be aligned with Regulatory Affairs)
• To advise the Director of Quality Operations on any matters arising which impact on supplier or service provider status or the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
• To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subject to temperature excursions and communicate to customers
• To ensure the systems and processes for the management of Product Technical Complaints and Product Recalls are being conducted in accordance with the licensed risk management and pharmacovigilance systems
• To act as Livingston site representative for Product Safety Review Board. Escalation of relevant issues to and from committee meetings/Global Quality Focus Groups
• To assist with the preparation, review and approval of technical / quality agreements for suppliers and service providers
• To prepare and / or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions
• In compliance with UK, EU/FDA quality rules and guidelines, to manage the resources, procedures and reports necessary to ensure effective execution of the external supplier audit program to a defined schedule, in conjunction with Global Quality Assurance
• In conjunction with QA, to perform external audits and internal audits as deemed necessary (e.g. for-cause investigations and unscheduled cGMP audits). Provide support to management during third-party audits
• To independently verify the audit reports and programme compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
• To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
• In conjunction with the concerned departmental personnel, develop suitable reporting mechanisms (e.g. key quality indicators) which provide assurance of effective quality oversight of both internal and externally contracted manufacturing and testing activities
• To keep up to date with current guidelines and regulatory requirements (e.g. Pharmacopoeial changes) in respect of quality requirements
• Implement and maintain Standard Operating Procedures, as required
• To undertake any other duties as requested by the line manager in accordance with company requirements

Person specification

• Degree level education or equivalent experience
• Eligible QP (UK qualified, under the Permanent Provisions)
• Relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment
• Good understanding and working knowledge of the Pharmaceutical Industry

Next StepsApply in the first instance online or by contacting Nichola Price at or on .Equal OpportunitiesFPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process