Hikal Job Vacancy For Developmental Quality Assurance
Hikal Job Vacancy For Developmental Quality Assurance |
We, Hikal Ltd, R&T Centre, Pune
Position: Executive - Developmental Quality Assurance
Experience - 5 to 9 years in API R&D Centre
Qualification - M. Sc. Organic or Analytical Chemistry
Salary - No bar for right candidate
Job Description:
Ø Review of specifications and test procedures of raw materials, recovered solvents, In process, Intermediate and final products.
Ø Review of lab development reports, technical package and supporting analytical data.
Ø Review of analytical method validation / verification protocols and reports, method transfer protocols and reports as per current regulatory guidelines.
Ø Review of purge study reports as per project plan.
Ø Ensure proper stage gate quality compliance at various stages of product development.
Ø Vendor qualification of key starting material and review of related technical documents.
Ø Review of structural elucidation reports as per project plan.
Ø Data archival, retrieval and storage with proper tracking system.
Ø Periodic review of SOPs and preparation of new SOPs to meet the requirements of QMS.
Ø Conduct periodic internal audits of synthesis as well as analytical labs to ensure compliance.
Ø Involvement in regulatory inspections, local authority inspections and customer audits at site.
Ø Review of documents required for regulatory submission and queries received from customer.
Ø Review of change proposals, deviations, lab incident reports received from synthesis and analytical department and timely closure of the same.
Ø Hands on experience for review of genotoxicity reports, nitrosamine and elemental risk assessment reports as per current regulatory guidelines.
Share Resume at - nishant_ghate@hikal.com
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