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 transparent, 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.

📌 Strategic Sourcing Reviewer (Bengaluru)
🏢 Biocon
📍 Bengaluru