Quality Systems Supplier Qualification Specialist
12 month contract
THE POSITION
You will ensure that the quality systems under your responsibility will be in adherence with the plans and expectations from the local and corporate quality teams. You will support the site Supplier Qualification program, ensuring management of records and data throughout the supplier lifecycle according to qualification principles. You will advise on the Supplier Qualification requirements defined by Boehringer Ingelheim Corporate Quality Assurance, Eudralex/MHRA and other regulatory bodies applicable to bio-pharmaceutical industries. You will work proactively as part of the site Quality Systems team with all general aspects of GMP and compliance. This role is based at our manufacturing site in Pirbright requiring a minimum of 3 days on site. This is a 12-month contract only.
TASKS & RESPONSIBILITIES
* Provides support to the Local Management System Owner to implement Supplier Qualification Governance in accordance with the Supplier Qualification Program:
o Supplier Identification
o Identification & documentation of Suppliers
o Definition of mitigation measures according to risk management principles
o Maintenance and oversight of Supplier Qualification governance across all relevant GxP departments
* Writes, reviews or approves documentation associated with Supplier Qualification:
o Quality Assurance Agreements
o Reference Documents
o SOPs
REQUIREMENTS
o Strong knowledge of supplier requirements as applied to a GMP facility
o Good knowledge of the principles of EU Good Manufacturing Practice (GMP)
o Past experience of working with QMS processes applicable to a GxP Pharmaceutical manufacturing environment
o Past Experience of working in a GMP Quality Control/Production department preferred
o Past experience of working in Computerised systems validation
o Strong written and verbal communication skills
o Excellent planning and time management skills
o The ability to utilise computer programs such as Visio, Microsoft Excel, Power Point, Outlook, DocuSign, as well as local electronic QMS tools
o Ability to work collaboratively across functions and form constructive relationships at all levels
WHY THIS IS A GREAT PLACE TO WORK
Boehringer Ingelheim has been recognised as a Top Employer in the UK. Being certified as a Top Employer confirms our dedication to a better world of work, delivered through excellent HR policies and people practices. To learn more visit: Boehringer Ingelheim Careers.
Seniority level: Associate
Employment type: Full-time
Job function: Project Management
Industries: Transportation, Logistics, Supply Chain and Storage
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