Hikal Job vacancy for Developmental Quality Assurance department check now

Hikal Job vacancy for Developmental Quality Assurance department check now 

Hikal Job vacancy for Developmental Quality Assurance department check now 

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 BELOW EMAIL ID - 

nishant_ghate@hikal.com

How to apply

Interested Candidates send CV Below Mail Id

nishant_ghate@hikal.com

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