QA Manager –Pharmaceutical Import and Export
Watford
Fantastic opportunity to join a well-established and expanding pharmaceutical wholesaler and distributor, exporting medicines across the world. Our client is looking for an experienced QA Manager to join its friendly team at its offices near Watford as the company continues to grow.
The role involves taking day to day responsibility for all quality.
Key stakeholders
Reporting directly to the Responsible Person who is also the CEO. Regular interactions with the Heads of Logistics, Warehousing, Customer Service and Sales.
Accountabilities
- Carrying out self-inspections of various departments and activities
- Assisting with the carrying out of audits of external service providers and suppliers
- Assisting with hosting of audits by clients and inspections by regulatory authorities
- Preparation for six-monthly GDP Management Review meetings including trend analysis
- Maintenance and updating of SOPs
- Bona fides checks on existing/new suppliers and clients
- Training of staff on SOPs and GDP
- Change control evaluation, approval and tracking including verification of their post[1]implementation effectiveness
- Handling and Investigating Customer and Supplier Complaints/Deviations.
- Handling and review of CAPAs including their tracking and verification of their post[1]implementation effectiveness
- Resolving quality queries with manufacturers/suppliers on matters such temperature stability data
- Risk assessment reviews
- Review and maintenance of Technical Agreements with clients, suppliers, logistics providers and other GDP service providers.
- Monitoring and complying with NCA updates on recalls, licences, products restricted for export etc.
- Acting as Quality Controller for batch release of relabelled products
- Prepare and submit WDA variations and renewals and Home Office Control Drug Licence renewals and applications for any other additional authorisations
- Application for Home Office CD import/export permits and other export licences and MHRA Notifications of Intentions to Import
- Co-ordination of transport route validation and validation of temperature-controlling packaging
- Maintain/develop a deep understanding of the pharmaceutical export industry to maximize the value we can offer our clients
- Keeping up to date with all relevant developments in GDP and GMP and ensuring that the company remains compliant in the face of an evolving regulatory landscape
- Work collaboratively with the rest of the team to support the ongoing development of the company
Essential skills & experience for this role include:
- Excellent knowledge of GDP, ideally with strong export experience
- Some knowledge of GMP helpful
- Very good written and verbal communication skills.
- Ability to develop strong external relationships and communicate effectively with different audiences, from NCAs, through to customers and service providers.
- Ability to develop strong internal relationships and to work collaboratively with the wider internal team
- Committed to the company’s ethos of delivering high levels of customer service and building long-term customer and supplier relationships
- Self-motivated, pragmatic, problem solver who is driven to succeed
- Excellent organisational skills and efficiency with ability to manage multiple tasks simultaneously
- Excellent attention to detail
- Experience using a CRM system, preferably SalesForce.com, advantageous and use of an order / inventory management system necessary
- Highly IT literate (Microsoft Excel, Word and Outlook)
- The ideal candidate will be a currently GPhC registered pharmacist who could act as Superintendent Pharmacist for our GPhC registered pharmacy
For more information apply now!
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