Quality Assurance - Welwyn Garden City, United Kingdom - Team Support Agency Care
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3 weeks ago
Description
My Client is a UK based pharmaceutical wholesaler Distribution Company and trades across Europe and Middle East, they also have subsidiary companies across EuropeProfile
You will be responsible for the operation and continuous improvement of the product Quality Management System based on global quality standards and local regulatory.
Responsibilities:
- Primary point of contact for the responsible person.
- Liaising with health authorities and inform/copy Company of any call/request by them pertaining distribution.
- Relations with warehouse incl. inspections at warehouse and training of relevant team members at warehouse and other departments if deemed necessary.
- Relations with manufacturers and/or licence holders.
- Control of Suppliers and Customers licences validation and contracts.
- Responsibility of returns, complaints and recalls in collaboration with Company where necessary.
- Creation and update of necessary procedures (SOPs) including training of relevant persons.
- Maintain and update licences.
- Keep all parties of Company informed about any new regulation or review which may impact on Company distribution activities.
GDP Responsibilities:
- Ensuring that a quality management system is implemented and maintained.
- Focusing on the management of authorised activities and the accuracy and quality of records.
- Ensuring that initial and continuous training programmes are implemented and maintained.
- Coordinating and promptly performing any recall operations for medicinal products.
- Ensuring that relevant customer complaints are dealt with effectively.
- Ensuring that suppliers and customers are approved.
- Ensuring that selfinspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
- Keeping appropriate records of any delegated duties.
- All regulatory reports including CAPAs/Change controls/Deviation/Risk Assessments should be written up to GDP standards.
- Requalifying existing suppliers and customers on annual basis for Acme and its foreign subsidiaries.
- Complete onsite temperature mapping of the warehouse and cold rooms.
- Review and maintain product quality SOP system.
- Working with the Pharmaceutical Sales and purchase team and provide inputs to the regulatory side of business within the company.
Skills and Experience Required:
Degree in Lifesciences and/or 2-4 years of experience in pharmacy or pharmaceutical sector.
Excellent customer service skills addressing the needs of both external and internal customers/suppliers with strong communication and process skills.
Competence in Microsoft Office suite - as a minimum Word, Excel, PowerPoint.
Working hours:
Mon-Friday 8:30-5:00 PM UK (40 hours per week)
Salary:
£30,000.00-£35,000.00 per year
Benefits:
- Company pension
Schedule:
- Monday to Friday
Supplemental pay types:
- Bonus scheme
Ability to commute/relocate:
- Welwyn Garden City: reliably commute or plan to relocate before starting work (required)
Work Location:
One location
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