Director of Operations 12 Month Fixed Term Contract GlasgowDo you have previous experience as an Operations Director within the biopharmaceutical industry? Can you perform well...
Equipment Validation Quality Team Leader - Permanent - Glasgow
Are you an experienced quality specialist with knowledge of equipment validation who can act as a subject matter expert in the application of the validation of equipment within a highly regulated GMP environment?
Are you looking for a new challenge, have you already gained or looking to further develop your experience within the biopharmaceutical industry? Can you perform well in a fast paced environment?
Can you work well in a team and also independently using your own initiative? Do you appreciate strong Company values? If you have these attributes you will fit in well with our client - Sartorius Stedim BioOutsource Limited.The Equipment Validation Quality Team Leader will take responsibility for the implementation and management of a system to meet UK and US regulatory requirements for all types of equipment qualification, maintenance and validation; which includes computer system validation and data integrity; with a strong focus on delivery, technical and regulatory content and quality.
In return our client can offer you a competitive salary, a generous benefits package, and significant opportunity for personal growth and development within a rapidly, expanding successful CRO.
What you can look forward to achieving
- Leading a small team of quality specialists in the documented validation compliance of equipment within a GxP regulated environment.
- Responsible for ensuring all validation requirements of appropriate regulatory bodies and pharmaceutical industry are met for equipment (including computer systems), service, maintenance, qualification and validation procedures, whilst maintaining good business cognisance, and providing guidance and training in these aspects internally.
- You will be capable of establishing validation policies, developing, reviewing and approving protocols, test results and making decisions on whether the equipment & or software is approved for use in a GxP environment.
Skills and experience that you need to bring to the Company
- A degree in a relevant scientific discipline
- Significant experience within a GMP regulated environment, or comparable experience
- Expert knowledge of IQ, OQ, PQ requirements for equipment within a life science GMP controlled laboratory.
- Thorough understanding and experience 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.
If you are interested in this exciting and challenging opportunity please apply online or contact Pamela for further information.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.