Executive/Sr. Executive- QMS

Experience: 5-9 years

Qualification: Post graduate (Biotech/Micro)

- 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.

Execcutive/Sr. Exectuive - Bioassay Exeprience: 5-7 years

Qulaification: M.Sc./M.tech/B.Tech (Biotechnology & Biochemistry)

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

Executive/Sr. Executive - Microbiology Experience: 5-9 years

Qualification: M.Sc. Microbiology

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.

Officer - Biochemistry

Experience :3 to 4 Years

Qualification: M.Sc./M.tech/B.Tech (Biotechnology & Biochemistry)

- Ensure compliance with company policies, safety standards, and regulatory guidelines.
- Ensure all lab reagents are in positive working condition and properly stored.
- Ensure the daily calibration and verification of instruments/equipment like Balances, pH/conductivity meter, Osmometer etc.
- Daily monitoring of temperature maintained chambers and other instruments.
- Responsible for Biochemistry lab related testing of in-process, finished products & stability samples as per approved procedures.
- Preparation of 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.

Interested candidate may share CV at [email protected]

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