Strategic Sourcing Reviewer

Job description

**About the Role** Is responsible for reviewing and verifying vendor’s qualification quality and regulatory documents, records, and compliance-related submissions to ensure accuracy, completeness, consistency, and alignment with GMP, regulatory, and company quality requirements. The role supports timely document review, vendor evaluation and audit readiness. **Responsibilities** - Review quality documents such as vendor documents like vendor qualification, quality, SOPs, protocols, reports, specifications, validation documents, and regulatory reports for accuracy and completeness. - Initial assessment of vendor quality system and cGMP. - Ensure that all reviewed records are clear, traceable, legible, attributable, contemporaneous, original, accurate, and complete. - Identify documentation gaps, inconsistencies, missing information, and compliance risks, and coordinate with relevant teams and vendors for timely correction. - Track review comments, pending actions, quality observations, and closure status to ensure timely completion. - Support internal audits, regulatory inspections, customer audits, and inspection readiness through document review and evidence preparation. - Work closely with R&D, CQA, Regulatory Affairs, Validation and Supply Chain, and other cross-functional teams. - Contribute to continuous improvement of documentation quality, review cycle time, error reduction, and compliance effectiveness. **Qualifications** - Bachelor’s or master’s degree in pharmacy, Chemistry, Microbiology, Biotechnology, Life Sciences, or a related discipline. - Relevant 6 - 10 years’ experience in pharmaceutical Quality Assurance, Quality Control, manufacturing documentation, batch record review, compliance, validation, or quality systems. - Experience in API and Generics, intermediates, or other regulated pharmaceutical manufacturing environments is preferred. - Hands-on exposure to GMP documentation, batch record review, deviation/CAPA review, change control, validation documents, and audit support is desirable. **Required Skills** - Strong knowledge of GMP, GDP, ICH guidelines, data integrity principles, and pharmaceutical quality documentation requirements. - Good understanding of batch records, SOPs, protocols, validation documents, deviations, CAPA, change control, OOS/OOT, and complaints. - High attention to detail with strong ability to identify errors, gaps, inconsistencies, and compliance risks in documents. - Strong analytical, review, investigation, and problem-solving skills. - Good communication and coordination skills to follow up with cross-functional teams for clarification and closure.