Careers with BDD
BDD are all about skills and passion. We believe that at BDD a rich, rewarding career and lifestyle that will surprise you with its breadth and potential. Just imagine the excitement and satisfaction of what you can do, where you can go, and the difference you can make.
Quality Assurance Officer
Location: BioCity Scotland, Bo’Ness Rd, Newhouse ML1 5UH and Bio-Imaging Centre, Medical Block, Glasgow Royal Infirmary, Glasgow, G4 0SF
Salary: £30-40K per annum DOE
Contract: Full time (37.5 hours per week), Permanent
BDD Pharma is a drug delivery company with ambitious expansion plans based in Glasgow, with clinical trial, formulation development and GMP manufacturing capabilities. BDD specialises in the development of novel pharmaceutical products using their patented timed-release technology, OralogiK™ and has recently secured investment to grow its manufacturing infrastructure to scale up development and GMP manufacture of this platform technology. The new GMP manufacturing facilities will be located at our BioCity site, and will encompass additional IMP manufacturing for BDD’s flagship combined formulation / clinical service, BDD SWIFT, which offers rapid clinically led formulation development through adaptive clinical trial designs.
An exciting opportunity has arisen within BDD for an experienced Quality Assurance professional to join our team. We are looking for a driven individual with a passion for quality, who will help us achieve our objectives to become the most highly respected small pharmaceutical company. With the development of our new GMP facility, there are opportunities for growth for an ambitious person who would like to grow and develop into a QA manager role.
Working within the Quality group, as Quality Assurance Officer you will be responsible for day-to-day Quality Assurance functionalities within BDD, maintaining and developing robust Quality Management System which meets both client and Regulatory Agency expectations. Ensuring that services and IMPs comply with all quality and regulatory requirements, you will establish, develop and maintain a quality improvement culture through open communication and close relationships with all departments.
Role responsibilities include:
• Quality Assurance functions at BDD sites and training and developing the Quality team
• Maintain QMS and ensure compliance with regulatory requirements: Deviation Management (including root cause analysis and CA/PA), Change Control, Documentation Control, Validation program, internal and external audits, metrics, complaints, product recall and training programmes
• Maintaining a continuous improvement system that will allow the consistent delivery of IMPs with appropriate quality attributes
• Maintaining a Quality Risk Management process for the assessment, control, communication, and review of risks to the quality of IMPs
• Support the company in obtaining an MIA(IMP) MHRA Licence for GMP activities at the new GMP facility
• QA activities surrounding manufacture, such as starting material release and batch review
• Plan, implement and maintain internal annual audit and self-inspection programs
• Supplier management including maintenance of approved vendor system
• Site audits and regulatory inspections
• Review data packages and client reports
• Maintain personal experience in UK/EU/USA regulations
The ideal applicant must:
• Have proven experience of prioritisation and time management
• Strong communication skills (written and verbal)
• Demonstrate an ability and willingness to help resolve complex problems as they arise
• Have a strong continuous improvement mindset
• Have the capability to work independently with minimal supervision
• Have excellent people skills and a proven ability to influence people to achieve objectives and drive performance
• Have a full driving licence (this role will require regular travel between BDD’s Biocity site and clinical trial facility located within Glasgow city centre)
Knowledge and experience:
• At least 3 years relevant experience within the pharmaceutical industry in a quality assurance role
• Experience in pharmaceutical production (specifically IMPs)
• Experience in execution of validation activities
• Demonstrable sound knowledge of UK, EU and US regulatory requirements and GMP guidelines (including risk management)
• Previous MHRA Inspection experience (desirable)
• Flexible working including ability to work from home in accordance with business needs
• Competitive salary package and a generous pension scheme, childcare vouchers and access to employee assistance scheme.
• 20 days’ annual leave per year rising to 25 (plus 10 bank holidays).
When applying for this role, please use your cover letter and CV to describe how you meet the competencies for this role as outlined in the job requirements above. The information that you provide will be used to assess your application. Please send your application via email to firstname.lastname@example.org
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