QA Senior Specialist
We have an exciting opportunity for a Quality Senior Specialist ready for a new opportunity.
Working within the Quality Assurance Department, this is a senior role which encompasses both oversight, monitoring and improvements of the QMS as well as the execution and management of the audit programmes. The successful candidate would therefore contribute to ensuring site compliance with Good Manufacturing Practices (GMP) and manufacturing licences.
Reporting directly to the Quality Manager.
Responsibilities and duties:
• Management of vendor audit and internal audit program including performing audits
• Management and Administrator of Trackwise and Quality Management Systems
• Management of GMP training programme, including preparation, execution and training
• Generation and monitoring of site quality metrics for Quality Review Board, monthly, quarterly and annual reporting
• Lead or participate in site quality objectives and quality improvement projects and investigations
• Support and participate in Health Authority Inspection audits and Global Ferring inspections including CAPA identification and implementation of CAPA
• Update, review and approval of procedures, records, specifications, risk assessments, reports and other associated documents.
Required Experience and competencies:
• A degree (BSc Hons or MSc) in pharmacy, quality or life-science discipline.
• Quality Assurance: 5 years
• Experience in pharmaceutical GXP regulated work or a highly regulated environment
• Experience in vendor management
• Experience as certified lead auditor
• Experience in Trackwise, metrics and quality management systems
• Proficient in Report writing
• Excellent time management skills and attention to detail
Preferred Experience:
• Medical Device/Combination Products
• Experience in using Trackwise, Veeva and SAP systems
What you get in return:
‘People come first at Ferring’, we offer our staff a welcoming and supportive environment across two campuses. In addition to a competitive salary we offer:
• Learning and development opportunities
• Performance Bonus Scheme
• 34 days leave, plus additional days for long service
• Employer’s pension contribution
• Flexible working opportunities including flexitime and working from home
• Private Medical and Dental Care
• Access to Occupational Health, Employee Assistance Programme and online support services
• Death in service benefit and income protection scheme
• Free onsite parking
About us:
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
To learn more about Ferring or its products please visit www.ferring.com.
Location:Ferring Controlled Therapeutics UKSimilar Jobs
What We Do
Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries.
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