Mivado GlobalPerformance is seeking a GxP Compliance Advisor who will act as the organization’s authority on GMP, GAMP, QA/QC workflows, and regulatory compliance.

This role ensures that every solution designed and implemented using a low-code platform aligns with real-world pharma operations and global regulatory expectations.

The incumbent will act as the credibility anchor during sales cycles, the process architect during implementation, and the compliance guardian throughout the customer lifecycle.

Key Responsibilities

1. Regulatory & Compliance Leadership

• – Interpret and apply global regulatory frameworks: GMP, GAMP 5, 21 CFR Part 11, Annex 11, WHO, MHRA, PIC/S.
• – Ensure that all solution designs adhere to data integrity principles (ALCOA+).
• – Advise clients on audit readiness and best practices for compliance.
• – Review validation deliverables (URS, FRS, Risk Assessments, IQ/OQ/PQ).

2. Process Mapping & Digital Transformation

• – Analyze existing pharma workflows (QA, QC, Manufacturing, R&D, Engineering).
• – Translate manual or legacy processes into optimized digital workflows.
• – Define functional requirements for modules such as:
  • • — eQMS (CAPA, Deviations, Change Control, Complaints)
    • –LIMS (sample management, stability, COA)
    • –MES/eBR (batch records, equipment logs)
    • –DMS (SOPs, controlled documents)
    • –EMS/eLogbook (equipment management)
• – Identify process gaps and recommend improvements aligned with industry standards.

3. Client Engagement & Advisory

• – Lead discovery workshops with QA Heads, QC Managers, Plant Managers, and IT teams.
• – Provide domain expertise during pre?sales demos and solution presentations.
• – Act as a trusted advisor throughout the customer journey.
• – Support Business Development with domain?specific insights and proposal content.

4. Implementation Support

• – Collaborate with implementation teams to ensure functional accuracy.
• – Validate workflow configurations, forms, dashboards, and reports.
• – Ensure system configurations align with regulatory expectations.
• – Participate in UAT planning, execution, and documentation.

5. Documentation & Validation

• – Review and approve:
  • • –URS/FRS
    • –Process maps
    • –Validation protocols (IQ/OQ/PQ)
    • –SOPs and training materials
• – Ensure documentation meets GxP and audit standards.

Required Skills & Qualifications

Education

• Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, or related field.

Industry Experience

• _  3+ years in pharma/biotech operations, QA, QC, manufacturing, or regulatory affairs.
• _ Experience with QMS, LIMS, MES, DMS, or other GxP systems is a strong asset.
• _ Hands?on involvement in audits, CAPA, deviations, change control, batch release, or lab operations.
• _ Deep understanding of GxP processes and digitalization trends.
• _ Ability to map business processes to software capabilities.
• _ Familiarity with CSV (Computer System Validation) principles.
• _ Strong analytical and documentation skills.

Soft Skills

• _ Excellent communication and presentation abilities.
• _ Strong stakeholder management and influence.
• _ Ability to simplify complex regulatory concepts.
• _ Close attention to detail and structured thinking.