Officer / Executive For Quality Control

For Executive -Bioassay

Exeprience: 5-7 years
Qulaification: M.Sc./M.tech/B.Tech (Biotechnology & Biochemistry)

Role & responsibilities

• Responsible for Bioassay lab related testing of finished products & stability samples as per approved procedures.
• Responsible for testing of analytical method transfer and validation of bioassay lab related testing methods (e.g., CDS assay, TNF alfa neutralization assay, Apoptosis assay etc but not limited to) for finished products samples.
• Cell bank preparation like master cell bank and working cell bank and its maintenance .
• 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.
• Maintain and calibrate laboratory instruments and equipment according to SOPs (Standard Operating Procedures) for Biochemistry lab.

For Executive - QMS

Experience: 5-9 years

Qualification: Post graduate (Biotech/Micro)

Role & responsibilities

• Handling of QMS e-modules,
• Handling of change control, deviations, CAPA and QRM.
• Support deviation investigations and CAPA implementation.
• Coordinate with production and QA teams for quality improvements.
• Review of master and executed documents for the compliance to actions defined in QMS.
• Preparation of SOP's related to governance (system)
• Preparation of APQRs
• Preparation of trends of QMS modules.
• Tracking of action items for its implementation on time.
• Participation and handling of investigations.

For Executive - Micro

Experience: 5-9 years

Qualification: M.Sc. Microbiology

Role & responsibilities

Ensure compliance with company policies, safety standards, and regulatory guidelines.

Supervision of sterility, BET, bioburden, and water testing.

Review of analytical records.

Investigation support for failures.

Training and qualification of analysts.

Coordination with production and QA.

For Officer- RM/PM

Experience: 2-5 Years

Qulaification:MSc. / B.pharma

Role & responsibilities

• Receive and verify the Good Inward Memo (GIM) for raw materials and packing materials in accordance with approved procedures.
• Perform sampling and labeling of RM/PM and water as per standard operating procedures.
• Conduct daily, monthly, quarterly, and annual calibration of laboratory instruments and equipment to ensure accuracy and reliability.
• Operate laboratory instruments and equipment such as pH meters, conductivity meters, UV cabinets, FTIR spectrometers, water baths, TOC analyzers, weighing balances, KF, Autotitrator and other relevant tools.
• Perform various tests including description, pH, conductivity, heavy metal analysis, Total Organic Carbon (TOC), identification tests, and others on raw materials, packing materials, finished products, and stability samples.
• Prepare volumetric solutions and reagents following approved procedures and safety guidelines.
• Maintain detailed records of test results, calibration data, and laboratory activities.

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