Quality Specialist / Engineer Permanent Central Belt of ScotlandAre you an experienced Quality Engineer/Specialist based in Central Scotland looking for a new challenge?Do you have...
Do you have previous experience as a Quality Specialist within the biopharmaceutical industry? Can you perform well in a fast paced environment? Can you work well in a team and also independently on your own initiative? Do you appreciate strong Company values? Then you will fit in well with Sartorius Stedim BioOutsource Ltd.
The post of Quality Specialist is a key supporting role in the Quality Department, reporting to the Quality Manager.
In return Sartorius Stedim BioOutsource Ltd. can offer you a competitive salary, a generous benefits package, full on the job training, and significant opportunity for personal growth and development within a rapidly expanding successful CRO.
What you can look forward to achieving:
The Quality Specialist will work closely with the Manager of Quality and the Operations team to ensure that the GxP quality systems are adhered to and followed by all staff.Amongst other duties, tasks will include:
- Performing internal audit functions
- Assisting and hosting client audits
- Reviewing and approving study raw data
- Approval of facility and process qualification/validation procedures and documents (facility, equipment, software, materials, personnel, etc.) according to GxP requirements
- Reviewing and approving all laboratory and other GMP, GLP and GCP documentation
- Assessing suppliers and supporting supplier inspections
- Assess impact of deviations and provide guidance, support and co-ordination of CAPA
- Review equipment validation documentation
Skills and experience that you need to bring to the Company:
- A degree in a relevant scientific discipline and Quality experience, preferably within a GMP or GLP environment with an understanding, and experience, of applying EU and US GMP and /or GLP regulations
- Extremely organised approach is required coupled with the ability to influence without authority
- Excellent written and verbal communication skills coupled with the ability to prioritise multiple tasks and have the confidence to challenge existing systems & processes
- Competent in Word, Excel and PowerPoint
This is a great opportunity to be part of a modern, dynamic business and would offer the right person excellent career development opportunities.
Please apply online or contact Emma for further information.