Analytical Chemist

**Title**: Analytical Chemist

**Reports to**: Manager - Research & Development

**Job Function**:

- Review all GMP analytical data generated as a part of testing
- Prepare study protocols as per requirements
- Review of study reports as per requirements
- This role would be for an individual contributor & there are no direct reports to this position.
- The person is required to work hand in hand with the development & GMP teams of the organisation. The lab activities/ work allocation/ work priorities will be managed by managers & team leads

**Duties and Responsibilities**:

- Audit laboratory documentation for compliance with quality & regulatory guidance's
- Conduct laboratory investigations and write deviations and LIRs
- Lead method development, method validation, method transfer, stability, characterization, and in-vitro bioequivalence activities for new pharmaceutical products
- Perform HPLC and GC testing (including troubleshooting and problem solving) and other required testing
- Evaluate all results generated for consistency and accuracy
- Develop specifications for finished product, bulk product, and raw materials
- Provide technical training to junior chemists to enable them to perform technical tasks
- Perform daily calibration of lab equipment such as balance, pH meter and Reverse Osmosis water unit as per SOPs

**Knowledge/Technical Skills**:

- M.Sc./Ph.D. in chemistry, biochemistry, pharmaceutical sciences or other relevant scientific discipline, or equivalent combination of education and industry experience
- At least 15 years in a relevant industrial environment of which the last 5 years should be in QA/reviewer role: generic or specialty pharmaceutical company; pharmaceutical contract service organization; analytical or formulation laboratory with ANDA directed projects
- Ability of collaborate & work with the current analytical team members
- Possess basic method development / QC review experience to critically review the data generated.

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

**Salary**: $60,000.00-$75,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off

Schedule:

- 8 hour shift
- Monday to Friday

Ability to commute/relocate:

- Concord, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

- How many years of experience do you have as reviewer in pharmaceutical industry?

**Education**:

- Bachelor's Degree (preferred)

**Speak with the employer**
+91 8219333489