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Quality Associate
3 months ago
Quality Associate / 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.
Alongside this, we also develop, implement and assist in the operation of WDAs for our clients, who are typically the Marketing Authorisation holders (MAH).
As such the role of RP is an important one within our business.- Hosting and responding to regulatory and client audits.
- Analysis of the clients' business model and creation of and adaption of an appropriate QMS.
- Consultancy advice to clients.
- Providing support to the Quality Team 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
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
- To act and be named as a Responsible Person.
- To carry out the duties of a Responsible Person as defined in EU GDP guidelines.
- Ensure that all technical agreements are prepared and maintained in line with regulatory requirements and any changes to scopes of work.
- To create and amend the QMS to reflect the clients' business models.
Role Requirements
- Minimum of 3 years' experience in a quality role within the pharmaceutical Wholesale Distribution sector.
- Experience across a range of medicinal products with varied storage conditions.
- Thorough understanding of current GDP requirements.
- Audit experience of GDP distribution facilities.
- Demonstrated high standards and attention to detail.
- Ideally with experience in import/export of medical products.
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 multidisciplinary 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. Ability to travel throughout the UK and EU.
Package Details
Competitive salary commensurate with experience, Annual performance related bonus, Contributory Pension, 25 days annual leave, East Midlands Office based minimum 2 days per week but flexible hybrid working arrangements available.
About Us
Callisto Pharma 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.
Job Types:
Full-time, Permanent
Schedule:
- Monday to Friday
Experience:
Pharmaceutical Wholesale Distribution: 3 years (required)
Work authorisation:
- United Kingdom (required)
Work Location:
Hybrid remote in Derby DE74
Reference ID:
RP-01-23
