Job Vacancy – Qualified Person (QP)
We are currently seeking an additional Qualified Person to join our team in a well-established and growing 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, both in the UK and Ireland, to enable the importation of medicines into both the EEA and the UK.
The role covers a variety of activities, in addition to batch release, across the GMP and GDP spectrum and will provide opportunities to grow and develop knowledge across a wide range of products and dosage forms.
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 released in accordance with GMP and regulatory requirements.
Key Duties and Responsibilities
- To ensure that systems and processes are robust and meet current regulatory expectations.
- To ensure all batches are manufactured in accordance with Good Manufacturing Practice and the requirements of the marketing authorisation.
- To carry out investigations of complaints and deviations and initiate appropriate corrective and preventative actions.
- To effectively manage the prioritisation, delivery and implementation of projects for clients in line with GMP expectations.
- To carry out audits of API sites, manufacturing sites, QC testing sites and storage sites including overseas sites.
- Preparation and review of technical reports.
- Provide support and input to the Regulatory team when required for Dossier applications.
- Eligible to act as a Qualified Person.
- Minimum of 5 years experience within the pharmaceutical sector in a Quality based role.
- Experience in manufacture of solid dosage forms (steriles experience would be an advantage).
- Thorough understanding of current GMP and GDP requirements.
- Proven record of implementing and maintaining quality systems.
- 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.
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 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.
Please send you application with CV to firstname.lastname@example.org quoting Reference ID: CAL2021-1-QP