Senior Executive | Assistant Manager - QA (Validation & Qualification)

Role & responsibilities

1. Documentation Review & Approval: Review and approve Batch Production Records, Validation Protocols, Change Controls, Deviations, and SOPs related to DS and DP manufacturing processes.
2. Regulatory & GMP Compliance: Ensure all activities related to Drug Substance and Drug Product manufacturing comply with applicable regulatory standards such as cGMP, FDA, EMA, and other international guidelines.
3. Validation & Qualification Support: Assist in the execution and review of Equipment Qualification, Process Validation, Cleaning Validation, and Method Validation activities for DS and DP.
4. Deviation & CAPA Management: Lead or support investigations into deviations, non-conformances, and out-of-specification results. Implement CAPA plans and monitor their effectiveness.
5. Change Control & Continuous Improvement: Manage change control processes related to DS and DP, ensuring proper assessment, documentation, and approval. Drive process improvements to enhance quality and efficiency.
6. Audit & Inspection Readiness: Prepare documentation and facilitate internal and external audits/inspections by regulatory agencies. Address audit findings and implement corrective actions.
7. Collaborative Support: Work closely with Manufacturing, Process Development, Validation, Engineering, and Regulatory teams to ensure seamless operations and compliance.
8. Data Integrity & Record Keeping: Maintain accurate, complete, and up-to-date records for all DS and DP activities in accordance with regulatory requirements.

Preferred candidate profile

Candidates having Vaccine Experience only be preferred.