Manufacturing Quality Specialist - Newhouse - Permanent Do you have previous experience as a QA Officer, Specialist or 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 our client - Sartorius Stedim BioOutsource Ltd. On behalf of our client we are looking for outstanding individuals who want to make an impact in a new exciting business area and can work effectively to deliver targets, manage by example and drive standards.Our client, Sartorius Stedim BioOutsource Ltd are building a new innovative manufacturing facility to deliver cell banking services and become the showcase facility for Sartorius products. They are looking for an experienced Manufacturing Quality Specialist to be responsible for assisting the manager in the day to day management of the Quality systems within this new state of the art facility. The successful candidate must have experience in applying EU and US GMP manufacturing regulations as well as being able to demonstrate excellent organisational and leadership skills.In return they 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
- Helping to set up, maintain and improve GMP compliant Quality Management Systems
- Ensuring systems are compliant, implemented, and are user, client, and business friendly.
- Providing advice / guidance on compliance issues including deviations and CAPAs as well as validation requirements
- Co-ordinating, reviewing and approving documentation and procedures in areas such as qualifications, validations, change control, supplier assessments and contractors to ensure compliance.
- Assisting the Lead in client and Regulatory inspections, and performing internal audit functions.
- Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Skills and experience that you need to bring to the Company:
- A degree in a relevant scientific discipline or comparable experience
- Previous Quality experience within a GMP or GLP environment.
- Thorough understanding and experience applying EU and US GMP , GMP Manufacturing regulations in particular and 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.
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 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.