SAP Business Quality Assurance (BQA) Consultant (Hybrid)

Overview

Hybrid
Depends on Experience
Contract - Independent
Contract - W2
Contract - 6 Month(s)
10% Travel

Skills

SAP BQA
manufacturing
GMP
CFR
ICH

Job Details

Title: SAP Business Quality Assurance (BQA) Consultant

Location: Indianapolis, IN (Hybrid)

Start Date: Immediate

Duration: 6 months

Interview: The interview will be conducted via Microsoft Teams.

Initially remote for 2 months and later Hybrid.

Job Description:

SAP 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 SAP 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

  • SAP Business Quality Analyst experience
  • 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

Total Yrs. of Experience

Up to 12 years

Relevant Yrs. of experience

7 to 12 years

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About Advantra Consulting Group