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 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, vali

📌 Strategic Sourcing Reviewer (Bengaluru)
🏢 Biocon
📍 Bengaluru