Q.C. Chemist - Quality

1. Job Objective

• Sampling and testing of incoming packing materials, raw materials, in-process samples , stability samples and finished products to ensure quality in compliance to GLP, cGMP, pharmacopoeia specifications and in-house norms.

1. Primary responsibilities

Strategic and planning

Functional

Core

1. Ensure quality of all incoming PM, RM, in-process materials, stability samples and finished products.
2. Sampling and testing of all PM, RM, in-process materials and finished product within lead time.
3. Timely preparation of testing reports and signing.
4. Sampling and testing of raw water and purified water as per specification.
5. Ensure correct labelling on materials, like- sampled, approved and rejected.
6. Ensure checking of dye strength of stock colour solutions.
7. Checking of preservative traces in equipment s undergoing in preservative free materials preparation.
8. Monitor GLP, GDP, c-GMP, ISO, FDA, 5S, internal audits and other such systems effectively.
9. Ensure effective implementation of in-process and final quality control checks.
10. Verification, calibration and validation of all Q.C. instruments on time.
11. Ensure EHS compliance in work place.

Internal process

1. Provide training to operators on GLP and other regulatory requirements.

People development

1. Key Result Areas

• Timely sampling and testing of all incoming PM, RM, in-process materials, stability samples and finished products.
• Verification, calibration and validation of all Q.C. instruments on time.

1. Key Interfaces

Internal Interfaces

External Interfaces

• Operations

• MSAT (TTT)

• Technical Services

• SciTech Centre

• Q&RA

• Customers

• External agencies/vendors

• Pin bar manufacturing unit