Overview
QA Compliance Specialist role at B. Braun Group. Location: B. Braun Medical, Brookdale Road, Chapeltown, Sheffield, S35 2PW. Working Hours: Monday–Friday, 37.5 hours per week. Contract: Permanent.
Responsibilities
* Supporting our Deputy Quality Assurance Manager in ensuring that our Aseptic Unit operates to a high standard within a highly regulated and controlled environment. You will be an independent member of the Quality team, providing technical expertise and support to the Aseptic manufacturing processes, ensuring compliance with GMP, policies and procedures.
* Maintaining a robust, effective and compliant sterility assurance and environmental control monitoring process in conjunction with the Production Supervisors.
* Provide coaching and mentoring to other functions on all aspects of the Quality Management System.
* Be visible in the manufacturing facility, acting as a role model for quality standards to Production Operators.
* Support and lead problem solving investigations with respect to sterility assurance and other quality issues.
* Take ownership of CAPA actions relating to Quality systems, and verify CAPA implementation and effectiveness.
* Participate in, and lead where required, non-conformance and quality incident investigations.
* Participate in change controls, providing technical advice and expertise.
* Participate in continuous improvement projects providing expert guidance for questions relating to sterility assurance and quality compliance.
What You’ll Need To Succeed
* Be educated to degree level in a scientific discipline or hold a BTEC equivalent in Pharmacy Services.
* Have proven experience in a Quality role, preferably with aseptic and clean room knowledge.
* Have at least 2 years’ experience in a GMP regulated facility.
* Have the ability and desire to train, coach and mentor others.
* Have the ability to analyse, apply and draw conclusions from large data sets.
* Be able to work under pressure and under your own initiative.
* Have strong IT skills, in particular with MS Office packages.
* Be a team player with good attention to detail and problem solving skills.
* Have auditing experience.
What You Get In Return
* 32 days annual leave plus bank holidays
* Discretionary annual bonus scheme
* 7% employer pension contribution
* 3x Salary life assurance
* Group income protection scheme
* Enhanced sick pay and family friendly payments
* Private medical insurance
* Health and wellbeing programme
* Employee assistance programme
* And much more…
Apply
Apply now. We look forward to receiving your application. Our Diversity and Inclusion commitment supports equal opportunities for all. Recruitment Advisors can assist with questions or adjustments through our online form.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Finance and Sales
* Industries: Medical Equipment Manufacturing
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