Hikal Job Vacancy For Developmental Quality Assurance

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