Executive-dqa

2 months ago

Pune Maharashtra, India Hikal Full time

Review of specifications and test procedures of raw materials, recovered solvents, In process, Intermediate and final products.
- Review of lab development reports, technical package and supporting analytical data.
- Review of analytical method validation / verification protocols and reports, method transfer protocols and reports as per current regulatory guidelines.
- Review of purge study reports as per project plan.
- Ensure proper stage gate quality compliance at various stages of product development.
- Vendor qualification of key starting material and review of related technical documents.
- Review of structural elucidation reports as per project plan.
- Data archival, retrieval and storage with proper tracking system.
- Periodic review of SOPs and preparation of new SOPs to meet the requirements of QMS.
- Conduct periodic internal audits of synthesis as well as analytical labs to ensure compliance.
- Involvement in regulatory inspections, local authority inspections and customer audits at site.
- Review of documents required for regulatory submission and queries received from customer.
- Review of change proposals, deviations, lab incident reports received from synthesis and analytical dept and timely closure of the same.
- Hands on experience for review of genotoxicity reports, nitrosamine and elemental risk assessment reports as per current regulatory guidelines.

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