Salary: £50,000 to £60,000
Contract Type: Full Time
Posted on: 3 December 2020
Our Clients who are one of the fastest growing independent Pharmaceutical Wholesalers in the UK are recruiting for a QARA Manager and Responsible person.
The main Job Purpose is to:
As QARA Manager, to provide QARA leadership and business acumen in driving successfully growth and as important compliance to the business. To lead QARA aspects of the business initiatives, improve systems whilst sustaining compliance and working in collaboration with the different departments within the business.
As Responsible Person, in line with EU and local regulations, maintain a high level of QMS and local regulatory knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential adversity with regards to Good Distribution Practice (GDP).
Quality Management Systems:
- Ensure continued certification to ISO9001 across the facilities
- Develop, implement and maintain an effective Quality Management System (QMS) that enhances the customer facing value of the organisation and reduced business risk whilst implementing legislation.
- Lead the continuous development of processes both internally and with third parties, driving productivity and quality. Implement best practice for existing processes in order to improve quality, efficiency and cost effectiveness using tools such as auditing and coaching.
- Key activities include ownership of management review, internal audit, CAPA and document control.
- Ensure that processes needed for the QMS are documented.
- Report to Top Management on the effectiveness of the QMS and any need of improvement.
- Ensure promotion of awareness of applicable regulatory requirement and QMS through the organisation.
- Take the lead role during external inspections under GDP or ISO9001.
- Proactively manage interactions and commitments to the Authorities’ inspection findings and site readiness.
- Review and assure annual self-inspection audits of processes , performing critical tests personally.
Responsible Person (RP)
To personally fulfil the duties of the Responsible Person defined by UK Health Authorities (MHRA) and the European Medicines Agency (EMA).
Gold Standard: Responsible Person Medicinal Products:
These responsibilities include, but are not limited to:T
- Ensuring that the provisions of the license are observed
- Ensuring compliance with the requirements of GDP guidelines both EU and MHRA
- Focusing on the management of authorised activities and the accuracy and quality of records
- Approving the initial and continuous training programme for all personnel involved in distribution activities
- Coordinating and performing promptly any recall operations of medicinal products
- Ensuring that relevant customer complaints are dealt with effectively
- Performing the qualification and approval of suppliers and customers
- Being involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products
- Review and sign off temperature records on a monthly basis and handle all temperature excursions. Ensure timely notification to the relevant party for all relevant product temperature excursions/status
- Ensuring that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC
- Ensure good morale within the team and promote a positive working environment
Competencies Required for this Job:
- Bachelor’s Degree in a scientific/technical discipline required
- A minimum of 3-5 years’ experience in a quality or compliance role within the pharmaceutical industry, most specifically in relation to GMP and GDP
- Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Strong Knowledge of regulatory requirements pertaining to GDP
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, HPRA, EMEA and other authorities
- Experience in auditing of external suppliers, contractors and vendors
- Previous experience working as a Responsible Person
- Excellent interpersonal skills
- Delegation and ability to train others
- Ability to operate as part of a team is critical
- Customer focus
- Excellent communication skills both written and verbal
- Registered as Responsible Person (RP) with the MHRA
- Knowledge and experience of applying pharmaceutical regulations relating to GDP
- Knowledge and experience of Quality Management Systems, including ISO9001
- Knowledge of Controlled Drugs regulations
- Knowledge of COSHH and Hazardous Transportation regulations
- Understanding of the management of storage and transportation of temperature sensitive pharmaceuticals
- Understanding of Standard Operating Procedures and Quality Management Systems
- Understanding and experience of auditing
- Pharmaceutical qualification