QA Manager Pharmaceutical

4 weeks ago


Watford, United Kingdom SKC Recruitment Ltd Full time
Role: QA Manager
Position Title: QA Manager – Pharmaceutical Import and Export
Reporting to: Head of Operations
Working Hours: 7.5-hour day, 37.5 hours per week (exact times to be agreed)
Annual Leave: 24 days plus Public Holidays
Salary: Competitive Package (Basic + Bonus)
Benefits: 32 days including bank holidays, 3% company pension contribution and 5% employee contribution (total 8%), 2 days per week home working, easy parking with dedicated parking over time..
Role Overview:
The QA Manager is responsible for overseeing all quality-related activities under both the company's WDA and its subsidiary's WDA, ensuring high standards of Good Distribution Practice (GDP). This role involves quality checks on products relabelled internally and offers an opportunity to progress to Responsible Person, Responsible Person (Import), and Quality Controller.
The position requires regular interaction with various departments, including Logistics, Warehousing, Customer Service, Sales, and Procurement, and reports to the Head of Operations while working closely with the Responsible Person.
Key Responsibilities:
* Conducting self-inspections across departments and activities
* Assisting with audits of external service providers and suppliers
* Hosting client audits and regulatory inspections
* Preparing for bi-annual GDP Management Review meetings, including trend analysis
* Maintaining and updating SOPs
* Conducting bona fide checks on existing and new suppliers and clients
* Training staff on SOPs and GMDP
* Evaluating, approving, and tracking change controls, including post-implementation verification
* Managing and investigating customer and supplier complaints/deviations
* Handling and reviewing CAPAs, including tracking and post-implementation verification
* Resolving quality queries with manufacturers/suppliers, such as temperature stability data
* Conducting risk assessment reviews
* Managing and maintaining Technical Agreements with clients, suppliers, logistics providers, and other GDP service providers
* Monitoring and complying with updates on recalls, licenses, and export restrictions
* Acting as deputy Quality Controller for the batch release of relabelled products
* Preparing and submitting WDA variations, renewals, and Home Office Control Drug Licence applications
* Coordinating transport route validation and temperature-controlled packaging validation
* Keeping abreast of industry developments in GDP and GMP to ensure ongoing compliance
* Collaborating with the team to support the company's development
* Upholding the company's core values
Qualifications, Skills, Experience, and Traits:
Essential:
* Extensive knowledge of GDP, with strong export experience
* Some knowledge of GMP is beneficial
* Excellent written and verbal communication skills
* Ability to build strong external relationships and communicate effectively with a range of audiences, from regulatory authorities to customers and service providers
* Strong internal collaboration skills, working effectively with the internal team
* Commitment to high levels of customer service and building long-term relationships
* Self-motivated, pragmatic, problem solver driven to succeed
* Exceptional organizational skills with the ability to manage multiple tasks
* Attention to detail and strong analytical skills
* Highly proficient in IT, including Microsoft Excel, Word, Outlook, CRM, and ERP systems
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