Business Quality Assurance

Job Description

Title: Business Quality Assurance (BQA)
 

Work Location: Cork and Limerick in Ireland, and in Florence, Italy

Domain: Life Science
Total Yrs. of Experience: Up to 12 years
Relevant Yrs. of experience: 7 to 12 years

Work Location: Ireland or Italy
Business Quality Assurance (BQA) is a key enabler to the initial implementation of the client’s manufacturing systems and ongoing sustainability. They ensure that the sites/areas can operate in compliance with Quality Standards and Practices. They provide business quality oversight to the corporate system on behalf of the sites/areas utilizing the system IT tools. 

Key Objectives/Deliverables:

• Subject Matter Expert for Data Integrity, cGMPs and business requirements for the IT system
• Represent business and Compliance (quality and data integrity requirements) across the manufacturing sites
• Provide Business Quality Analyst support for manufacturing systems implementation, including document approvals for GMP related changes
• As quality issues arise, support/drive the potential global/system impact and ensure quality issues are addressed in a timely manner.
• Assist business partners in defining global requirements and in developing global business cases.
• Enforce standards and procedures within the team and with the external service providers.

Experience:

• Experience as a quality assurance representative supporting manufacturing/QC processes.
• Strong knowledge of quality business processes and quality requirements.

Mandatory skills:

• Strong knowledge in GMP, cGMP, regulatory standards (21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, ICH Q7)
• Experience in facing FDA audits associated with pharma manufacturing units
• Hands-on experience with manufacturing processes, CAPAs, deviations etc.
• Lead Auditor or any other compliance certifications will be beneficial