Job Description:
People come first at Ferring! Do you want to be part of a growing and hugely successful business who put people and families at the heart of what we do?
Ferring Controlled Therapeutics Ltd is a pharmaceutical manufacturing facility located on two sites in East Kilbride, Glasgow. Our facility houses 120 employees across 2 functions: manufacturing and pharmaceutical & analytical development.
We are recruiting for a dynamic, experienced QA Specialist to support our energetic and friendly department. The successful candidate would contribute to ensuring site compliance with Good Manufacturing Practices (GMP) and manufacturing licences for marketed products and clinical trials.
This full time, permanent role will work alongside the QA team and report directly to the QA Manager. Working flexitime hours Monday to Friday, with onsite car parking and an excellent benefits package, this role is available for an immediate start.
Responsibilities and duties:
- Product subject matter expert
- Review and approval of batch records, validation reports and other associated documentation
- Approval of incoming goods
- Perform room authorisation checks during manufacturing and packaging processes
- Generation of Product Quality Reviews
- Perform Internal Audits
- Participate in Health Authority Inspections
- Perform GMP Training
- Operate Complaints, Deviations, CAPA and Change Management systems
- Manage regulatory changes
- Maintain device documents for Combination Products
- Artwork management and specifications
- Generation and monitoring of Site Quality Metrics
- Lead and contribute to quality improvement projects and investigations
Required Experience and competencies:
- A degree (BSc Hons or MSc) in pharmacy or life-science discipline.
- Quality Assurance: 5 years (Preferred)
- Experience in investigation and root cause analysis tools
- Previous us of Excel, power point and word
- Proficient in Report writing
- Excellent time management
- Excellent attention to detail
Preferred Experience:
- Experience in pharmaceutical GXP regulated work or a highly regulated environment
- Medical Device/Combination Products
- Experience in using Trackwise, Veeva and SAP systems
What you get in return:
‘People come first at Ferring’. We offer you support to help you succeed in your new role with coaching and development from onboarding onwards, and opportunities to progress your career. In addition, to reward you for your hard work you’ll get:
- Ferring Global Bonus Plan
- Annual merit review
- Enhanced employer’s pension contribution
- 25 days’ annual leave, plus 9 bank holidays
- Flexible working schedule
- Enhanced Maternity & Paternity Policy
- Private medical and dental care plans
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 UK