Job Vacancy – Lead Auditor and Responsible Person (RP)

We hold our own MIA and Man A, both in the UK and Ireland, to enable the importation of medicines into both the EEA and the UK.

As Lead Auditor the role will cover the management of vendor assurance activities including

• Preparation and review of technical agreements.
• Management of internal and external audit programs.
• Performing audits, based on risk, of API manufacturers, contract manufacturers, laboratories and storage sites.
• Assessing any audits conducted by 3rd parties and ensuring suitability.

You will also carry out the duties of a Responsible Person including

• 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.

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

• 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.
• To conduct audits of any outsourced manufacture, testing or storage on behalf of Callisto, Elara and their clients.
• 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.

Role Requirements

• Lead auditor or able to act as a Responsible Person (training will be provided to the right candidate).
• Minimum of 5 years experience within the pharmaceutical sector.
• Knowledge of a range of dosage forms.
• Thorough understanding of current GMP and GDP requirements.

Behavioural Competence

• 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.

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

Application

Please send your application and CV to jo@callisto-consulting.co.uk quoting Reference ID: CAL2021-2-RP