Executive/Sr. Executive - Quality Control

Designation: Executive/Sr. Executive

Experience: 5-10 Years

Biochemistry

Role & responsibilities

• Ensure compliance with company policies, safety standards, and regulatory guidelines.
• Responsible for Biochemistry lab related testing of in-process, finished products & stability samples as per approved procedures.
• Preparation and review of all documents like SOP, Protocols, Reports, STP, Specification, but not limited to.
• To ensure the procurement of consumables, chemicals, laboratory ware, but not limited to.
• Responsible for testing of analytical method transfer and validation of biochemistry lab related testing methods (e.g., Host Cell Protein (HCP), Host Cell DNA (HCD), Residual Protein A (RPA) CE-SDS (Capillary Electrophoresis), SDS, WBT etc but not limited to) for in-process samples and finished products.
• Maintain and calibrate laboratory instruments and equipment according to SOPs (Standard Operating Procedures) for instrumentation lab.

Instrumentation Lab

Role & responsibilities

• Ensure compliance with company policies, safety standards, and regulatory guidelines.
• Responsible for instrumentation related testing of in-process, finished products & stability samples as per approved procedures.
• Preparation and review of all documents like SOP, Protocols, Reports, STP, Specification, but not limited to.
• To ensure the procurement of consumables, chemicals, laboratory ware, but not limited to.
• Responsible for testing of analytical method transfer and validation of instrumentation testing methods (e.g., SE-UPLC, CEX-HPLC, Protein concentration by OD280 method, Protein concentration by slope spectroscopy, Peptide Mapping by HPLC, HILIC by UPLC, RP-HPLC, but not limited to) for in-process samples and finished products.
• Maintain and calibrate laboratory instruments and equipment according to SOPs (Standard Operating Procedures) for instrumentation lab.

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