We are looking for a QA Specialist to join the Quality team at Sartorius Stedim BioOutsource – Cell Bank Manufacturing team. In this role, you will be responsible for reviewing and approving Batch Manufacturing Records, carrying out the Batch Release process, working closely with the QP, internal and external supplier audits as well as working closely with customers.
The team consists of 5 professionals, and we are looking forward to shaping the future with you.
This position is available full-time on a permanent basis and it is an on-site role at our Newhouse site near Motherwell.
- You will be reviewing and approving Batch Manufacturing Records related to cell bank manufacturing and sterility and Mycroplasma testing
- Quality review of paperwork for batch release process, working closely with the site QP, Quality team members, QC and Manufacturing team
- Review of all QMS documents, e.g.validation documentation, Change Control, CAPA, Material Specifications, Logbooks and forms, SOP Review and Update
- Prepare Quality Metrics
- Conduct and co-ordinate internal audits of processes and external supplier audits, host audits conducted by regulatory bodies such as MHRA
- Work closely with customers to ensure products meet customer expectations and demand
- Ensure all batches manufactured are adhering to quality standards as well as GMP regulations
- Use Tracwkise Digital for change controls, CAPAs
- Use of Electronic Data Management System
- Address any issues of non – compliance and ensure quality is an integral part of all processes and procedures
- Support the quality team in projects from moving from paper based QMS to an electronic QMS
You will be reviewing and approving Batch Manufacturing Records related to cell bank manufacturing and sterility and Mycroplasma testing
Quality review of paperwork for batch release process, working closely with the site QP, Quality team members, QC and Manufacturing team
Review of all QMS documents, e.g.validation documentation, Change Control, CAPA, Material Specifications, Logbooks and forms, SOP Review and Update
Prepare Quality Metrics
Conduct and co-ordinate internal audits of processes and external supplier audits, host audits conducted by regulatory bodies such as MHRA
Work closely with customers to ensure products meet customer expectations and demand
Ensure all batches manufactured are adhering to quality standards as well as GMP regulations
Use Tracwkise Digital for change controls, CAPAs
Use of Electronic Data Management System
Address any issues of non – compliance and ensure quality is an integral part of all processes and procedures
Support the quality team in projects from moving from paper based QMS to an electronic QMS
What will convince us
- You may have a degree in a relevant subject.
- Experience in a quality role within GMP manufacturing within the pharmaceutical or biotech industry
- Experience in auditing would be beneficial
- Excellent skills in Microsoft packages especially Excel as working with spreadsheets on a day-to-day basis
- Good communication skills and the ability to interact with other departments
- Good organizational skills with the ability to multi – task, prioritize and manage own workload
You may have a degree in a relevant subject.
Experience in a quality role within GMP manufacturing within the pharmaceutical or biotech industry
Experience in auditing would be beneficial
Excellent skills in Microsoft packages especially Excel as working with spreadsheets on a day-to-day basis
Good communication skills and the ability to interact with other departments
Good organizational skills with the ability to multi – task, prioritize and manage own workload
In order to commence working with us, the successful candidate must have the right to work in the UK.
What we offer
As a growing global life science company, stock listed on the German DAX and TecDAX, Sartorius offers a wide range of benefits:
- Making an impact right from the start:Comprehensive onboarding, including a virtual online platform–even before joining
- Welcoming Culture:Mutualsupport, team-spiritand international collaboration; communities on numerous topics such as coaching, agile working andbusinesswomen network
- Health & Well-Being: Wide section of health and well-being support such as healthcare plans and health assessment services
Making an impact right from the start: Comprehensive onboarding, including a virtual online platform – even before joining
support, team-spirit businesswomen network
Health & Well-Being : Wide section of health and well-being support such as healthcare plans and health assessment services
Benefits
Attractive Working Conditions
- 35 hours working week
- 29 days annual leave, plus public holidays
- Annual option to buy, sell or carry over annual leave
- Free parking on site
- Free hot and cold drinks
- Regular social events
35 hours working week
29 days annual leave, plus public holidays
Annual option to buy, sell or carry over annual leave
Free parking on site
Free hot and cold drinks
Regular social events
Health & Wellbeing
- Competitive benefits package, including:Private Medical InsurancePrivate Dental InsuranceGroup Life AssuranceTravel Insurance (Employee Paid)Salary Sacrifice Health Assessment ServiceSalary Sacrifice Cycle to Work Scheme
- Private Medical Insurance
- Private Dental Insurance
- Group Life Assurance
- Travel Insurance (Employee Paid)
- Salary Sacrifice Health Assessment Service
- Salary Sacrifice Cycle to Work Scheme
Competitive benefits package, including:
Private Medical Insurance
Private Dental Insurance
Group Life Assurance
Travel Insurance (Employee Paid)
Salary Sacrifice Health Assessment Service
Salary Sacrifice Cycle to Work Scheme
Planning Ahead For Your Future
- Group Personal Pension Plan
- Group Income Protection
- Salary Sacrifice Will Writing Service
Group Personal Pension Plan
Group Income Protection
Salary Sacrifice Will Writing Service
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.