Company DescriptionAudit & Align CGMP Compliance Services specializes in strengthening Quality Management Systems (QMS) and CGMP compliance for pharmaceutical organizations. The company focuses on regulatory excellence, process integrity, and sustained audit readiness, backed by deep expertise in ISO 9001:2015,global GMP auditing frameworks, and technical training. Our core capabilities encompass:
• Independent GAP and mock regulatory inspections.
• Comprehensive vendor management solutions, including raw material vendor qualification and periodic supplier audits.
• Regulatory remediation services to address FDA Form 483 observations, Warning Letters, and global agency inspection findings.
• End-to-end consulting for Greenfield projects, spanning Quality Control (QC) laboratory setup, facility readiness, and foundational Quality function documentation.
• Retrospective QMS document review and authoring of robust SOPs, equipment qualification protocols,and QC laboratory systems.
• Advisory and deployment support for digital quality solutions (such as TrackWise, SAP, LIMS, CDS, and e-DMS) to maximize data integrity, operational traceability, and efficiency. Audit & Align champions continuous improvement, risk-based thinking, and a zero-tolerance culture for non-compliance across pharmaceutical operations. Role DescriptionRole: GxP Auditor & Quality Consultant, Pharmaceuticals Type: Full-time, On-site

Location:
Solapur, Maharashtra The GxP Auditor & Quality Consultant will lead and execute comprehensive compliance assessments,vendor oversight, and regulatory remediation programs for pharmaceutical clients. This hands-on role involves conducting rigorous GxP/CGMP audits—including internal GAP analyses, mock regulatory inspections, raw material supplier qualifications, and periodic vendor audits—accompanied by actionable CAPA design. In addition to auditing,



the consultant will play a critical role in supporting Greenfield manufacturing and laboratory projects, guiding the planning, design, equipment setup, and procedural workflows of current Quality Control (QC) laboratories. The consultant will also lead remediation efforts for regulatory enforcement actions (such as FDA Form 483s, Warning Letters, and import alerts), working directly with client leadership to restore regulatory standing. Day-to-day responsibilities also include comprehensive documentation support across all Quality functions (QA, QC, and validation), reviewing and optimizing SOPs, qualification protocols, and digital system integration (TrackWise, SAP, LIMS, CDS, e-DMS), while delivering impactful GMP training across cross-functional teams.

Key Responsibilities
• Auditing & Vendor Qualification: Plan, execute, and report on GxP/CGMP internal audits, mock inspections, and external raw material vendor qualification audits, establishing risk-based periodic supplier audit schedules.
• Regulatory Remediation: Formulate strategic CAPA plans and remediation roadmaps in response to US FDA Form 483 observations, Warning Letters, and other health authority inspection findings.
• Greenfield QC Setup: Provide technical and regulatory guidance for Greenfield projects, including QC laboratory layout review, instrument procurement specifications, workflow design, and testing methodology setup.
• Documentation & QMS Support: Provide comprehensive documentation support across Quality Assurance and Quality Control functions, including drafting, reviewing,



and optimizing SOPs, validation master plans (VMP), qualification protocols (DQ/IQ/OQ/PQ), specifications, and STPs.
• Data Integrity & Digital Systems: Assess and assist with the validation and adoption of electronic quality and lab systems (TrackWise, SAP, LIMS, CDS, e-DMS) to reinforce data traceability and compliance.
• Training & Advisory: Deliver targeted GMP, data integrity, and audit-readiness training sessions to cross-functional plant and corporate teams. Qualifications & Competencies
• Auditing & Compliance Expertise: Proven track record in planning, conducting, and reporting on GxP/CGMP audits, including mock regulatory audits, supplier audits, and raw material vendor qualification programs.
• Regulatory Remediation

Experience:
Direct experience in root-cause investigation, drafting regulatory responses, and executing remediation programs for FDA Form 483s, Warning Letters, or similar international agency citations.
• Greenfield & Laboratory Knowledge: Demonstrated experience with pharmaceutical QC setup,laboratory workflow optimization, and commissioning/qualification of analytical instruments in Greenfield or expansion settings.
• Quality Function Documentation: Extensive hands-on capability in generating and reviewing technical documentation across QA, QC, and validation streams (SOPs, STPs, protocols, risk assessments).
• Systems & Data Integrity: Practical familiarity with enterprise and laboratory software tools including TrackWise, SAP, LIMS, CDS, e-DMS, and 21 CFR Part 11 requirements.
• Training & Coaching: Demonstrated ability to mentor and train cross-functional plant personnel on CGMP culture, audit preparation, and risk-based decision-making.
• Education & Certifications:
• Master’s degree in In-Organic Chemistry .
• Certified ISO 9001:2015 Lead Auditor.

📌 GxP Auditor, Consultant, Pharmaceuticals (Solapur)
🏢 audit & align cgmp compliance services
📍 Solapur