Biocon
Website:
biocon.com
Job details:
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.
Click on Apply to know more.
