Do you have previous experience as a Quality Auditor 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, based in Glasgow.
The post of Quality Auditor is a key supporting role in the Quality Department, reporting to the Quality Manager.
What you can look forward to achieving
The Quality Auditor will work closely with the Quality Specialists/Associate Director 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
- 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 of Environmental Monitoring results/reports
- Reviewing and approving all laboratory and other GMP, GLP and GCP documentation
- Assessing suppliers
- Assess impact of deviations and provide guidance, support and co-ordination of CAPA
- Review equipment validation documentation
In return we 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.
Skills and experience that you need to bring to our Company:
- A degree in a relevant scientific discipline and/or at least three years 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.
Closing Date Friday 13th May 16
How to Apply:
Please send a copy of your CV along with a covering letter.