Qualified Person - Livingston, United Kingdom - Valneva

Valneva

Verified Company

Livingston, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

As a QP, you will be responsible for performing the legal and routine duties with respect to the review, approval and certification of licensed and investigational products.

To maintain effective quality oversight of internal and external contract manufacturing and testing activities in order to verify that local and Global Quality Systems/procedures are defined, being adhered to, are operating effectively and comply with UK, EU, FDA, RoW regulatory requirements.

Requirements:

Your Responsibilties

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 Annex 16 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 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. forcause investigations and unscheduled cGMP audits). Provide support to management during thirdparty audits
To independently verify the audit reports and programme compliance, escalate any adverse trends or major nonconformances 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

Requirements:

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