Job Description

Key Responsibilities:

• Develop, revise, and maintain GxP procedural documentation , SOPs, and process maps.
• Collaborate with subject matter experts, business process owners, and stakeholders to ensure documentation aligns with compliance and operational needs.
• Create clear and engaging training materials, job aids, and process workflows that support operational excellence.
• Ensure all documents meet global regulatory and inspection-readiness standards .
• Evaluate existing documentation to identify gaps and recommend continuous improvement opportunities.
• Contribute to audit readiness and compliance initiatives.

Qualifications:

• Bachelor’s degree required; advanced degree preferred.
• 7+ years of experience in pharmaceutical documentation, SOP writing, and process development .
• Strong background in GxP (Good Practice) environments — Pharmacovigilance (PV) experience is a major plus.
• Excellent project management and multitasking skills (PMP certification a plus).
• Skilled in Visio for process mapping and MS Office / SharePoint / Teams .
• Proven ability to work under pressure while maintaining accuracy and detail orientation.

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