- Ensuring the Quality Management system is implemented, maintained and subject to continuous improvement
- Hosting and responding to regulatory and client audits
- Ensuring all activities are compliant with regulatory requirements and terms of the licence
- Assessing the impact of any deviations on product stored
- Ensuring self-inspections are performed and that any subcontracted activities are suitably assessed
- Provide support and input to the Regulatory Affairs team when required
- Providing support to the Quality Assurance Manager to ensure the efficient and effective operation of the Quality Management Systems (QMS).
- To ensure the timely and accurate collection and recording of information within the QMS to allow Key Performance Indicators (KPIs) to be monitored.
- To provide technical and quality system support to the wider business
- To act and be named as a Responsible Person.
- To ensure systems are in place that ensure products are transported, stored and distributed in a safe and secure manner
- To ensure facilities used for the storage of medicinal products are suitable in terms of security, segregation, prevention of cross contamination and temperature
- To ensure written procedures are in place for all GDP activities
- Ensure that a system is in place to ensure all relevant audits have been conducted and that ongoing compliance is achieved by the use of risk assessment tools.
- Ensure that all technical agreements are prepared and maintained in line with regulatory requirements and any changes to scopes of work.
- Minimum of 3 years' experience within the pharmaceutical Wholesale Distribution sector working with a WDA QMS.
- Currently named as an RP on a Licence with the MHRA
- Knowledge of a range of dosage forms.
- Thorough understanding of current GDP requirements.
- Audit experience of GDP distribution facilities
- Customer Focus: Good communication skills (verbal and written). Able to obtain information from customers to deliver the requirements of the role. Works to deliver best service to customers and manage their expectations.
- Teamwork: Can work well in a multi-disciplinary team and across teams to deliver requirements of role.
- Quality and Safety: Understands the quality standards required for the role and supports continuous improvement. Able to manage own performance to deliver on agreed objectives.
- Flexibility: Able to adapt to meet the needs of the business at any point in time.
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Responsible Person - Lockington, United Kingdom - Callisto Pharma Group
Description
Job Description
Quality Associate / Responsible Person (RP)
Due to continued expansion, we are currently seeking a Quality Associate / RP to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical space.
We hold our own MIA and ManA, and controlled drug licences, both in the UK and Ireland, to enable the importation of medicines into both the EEA and the UK. We also develop, implement and assist in the operation of WDA's for our Clients. As such the role of RP is a critical one within our business.
You will carry out the duties of a Responsible Person including
The wider role of Quality Associate would cover
You will work alongside the internal Quality team and our Clients to continually improve systems and maintain ongoing compliance ensuring that all products are manufactured and distributed in accordance with GMP/GDP and regulatory requirements.
Key Duties and Responsibilities
Role Requirements
Behavioural Competence
Package Details
Competitive salary commensurate with experience, Annual performance related bonus, Contributory Pension, 25 days annual leave, East Midlands Office based but flexible working arrangements available.
The role is a full time permanent position.
About Us
The Callisto Consulting Group has grown from the formation, in 2003, of Callisto Regulatory Consulting Ltd, which provided regulatory and technical support to pharmaceutical manufacturers to a group comprising of three companies that can provide a complete range of technical services across the whole supply chain to multiple regulated sectors including human, veterinary and herbal medicines, borderline products, biocides, medical devices and food supplements.
We work across the UK, Europe, and the rest of the world for Clients operating in highly regulated sectors, ranging from global multi-nationals to single product licence holders.
We are committed to investing in our people and infrastructure which enable us to be highly flexible, efficient and innovative in our services to Clients
