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Document Reviewer

5 months ago

Barasat, India Edward Food Research & Analysis Center Limited (EFRAC) Full time

**Location : Barasat**

Contributing to the accomplishment of the Analytical development function objectives. The position will report to **Manager - Drug Lab**. The role would be involved in the below mentioned areas:

- Preparation and review of Specifications, Method of analysis procedures and Analytical development reports.
- Preparation and review of analytical protocols and reports (Analytical method validation, Method feasibility, Analytical method transfer, etc.).
- Establishing In-house systems and procedures to ensure cGLP practices & regulatory requirements for analytical activities at In-house R&D facility.
- Trouble shooting related to Testing methods, Stability studies, test results and designing of additional experimentations as necessary
- Execution & coordination for Analytical method transfer activities of drug products.
- Technical assessment & Analysis of drug substances (API) for projects execution.
- Review & clearance of technical documents leading to dossier batches executions and registrations.
- Technical assessments of projects (Screening, pipeline and development projects stages) & Literature search).
- Preparation of analytical technical documents for dossier / Technology transfer executions / Regulatory submissions of projects.
- Assisting and resolving technical quries raised during Technology transfer activities & regulatory submissions.
- Assisting in establishment of In-house Infrastructure (Analytical equipments Qualifications and preparation of SOP’s).

**Job Types**: Full-time, Permanent

**Salary**: ₹10,000.00 - ₹20,000.00 per month

**Benefits**:

- Paid time off
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Barasat, West Bengal (required)

Ability to Relocate:

- Barasat, West Bengal: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**

+91 9695323379