Department Details

Role Summary

QA - Regulatory and Customer support

Key Responsibilities

Overall responsible for Regulatory support & compliance
• Collaborate with CFT to ensure compilation & documentation for timely regulatory submissions.
• Develop, maintain & track timelines for regulatory submissions, ensuring that documents are prepared, reviewed, & submitted according to established deadlines.
• Review of analytical data pertaining to various testing of materials
• Review & approval of specifications, MoA, ODS, SOP; validations/verification/qualification & method transfer activities/working,certified & impurity standard Qualification & COAs; floating formats; qualification /re-qualification document/mapping activities; IUT; warehouse discrepancies notes
• Issuance, re conciliation; retrieval & archival activity
• Coordination for APQR activities/ technology transfer activities.
• Coordination with audit management team for completion of audits successfully/risk assessment.
• SCM related activities/requirement/meetings & data preparation.




• Support queries from marketing & SCM functions on product quality & business requirements.
• Assist regulatory science department for product filings.
• Handling of customer queries on analytical data of product/Errata
• Ensure timely completion of training. Review & accept the JD formally presented by the reporting manager.
• Ensure timely & accurate documentation is maintained on principles of GDP & DI
• Addressing the data integrity/GDP non-conformance & escalating to senior management.
• Keep abreast about the roles & responsibility of quality department
• Providing insights for site specific SOPs/corporate
• Issuance, retrieval, archival & destruction of GXP document
• Keep abreast of the quality/EHS policies/procedure adherence & emergency preparedness & response plan.
• Procedural governance for assigning retest date & expiry date for material
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•Ensure that training is completed with successful certification on

📌 Assistant Manager (India)
🏢 BIOCON PHARMA
📍 India