Qualified Person
Job Purpose
Drive compliance to MHRA Regulatory and Company requirements/standards by working and collaborating with multifunctional teams and providing quality leadership. To act as site QP, ensuring that site is maintained in a state of compliance and each batch is released according to cGMP and product registration.
Main Duties
All duties to be performed in line with agreed departmental KPI’s where relevant.
• Perform duties of a Qualified Person
o Release of Batches.
o Support operations by advising on compliance and quality related issues including any potential batch rejections.
o Deviation support for all departments in ensuring any deviation from process or procedure is appropriately assessed, managed and resolved to ensure both product quality, safety and efficacy are maintained and in compliance with cGMP
o Attend operations morning meetings.
o MOM and MFC/MFB approval.
o API QP declarations.
o Ensuring all requirements as stipulated in Annexe 16 are complied with.
• Provide QP input to key quality systems: change control, customer complaints, PQRs, product investigations, RA strategies, supplier management, validation and any product recall (this list is not exhaustive).
• Review and approval of quality system documentation as part of the QA Leadership including but not limited to technical agreements, artwork, procedures, validation reports, change controls.
• Assist in supporting operational compliance by applying quality risk management tools and principles in assessments and investigations, in order to support compliance decisions. This support is provided both formally in investigation meetings/ document reviews and also on an ad hoc basis via on the floor conversations with stakeholders at all levels of the business and in recurring forums such as attendance to the daily Operations and QC meetings and weekly review meetings.
• Involved in the interpretation and implementation of revised regulations and guidance documents pertaining to GMP requirements. This work may involve cross-site collaborations with other sites both within UK and internationally.
• Participation in change control and CAPA review boards
• Conduct both internal and external audits as required.
• To support external and internal audits by acting as subject matter expert.
In addition to the duties and responsibilities listed, the jobholder is required to perform other duties assigned by your Manager.
Role Requirements
• The successful candidate will have a scientific degree qualification working to both EU and US GMP requirements. The candidate must be eligible for being named on a manufacturing license as a Qualified Person
• This experience must include previous experience in internal and external auditing, validation and operational- support in a QA role.
• Experience in the application of Quality Risk Management tools is a requirement.
• Experience in management of department-level projects would be advantageous.
• The successful candidate is expected to demonstrate a keen interest in current trends within the industry and how these trends can be actively adapted into site improvements. This role will appeal to an energetic and self-driven professional who is willing to both lead and participate in group activities in order to achieve company successes.
• Experience in non-sterile liquid (Essential)
• Experience in other galenic forms
• Experience in releasing IMP’s