Qc - (Lvp)

1 week ago


Patas Pune Maharashtra, India Steribio Lifesciences Pvt.Ltd Full time

**Education**:

- M.Sc. in Organic Chemistry, Microbiology, or a related field.
- **Approve** -FDA
- **Reports To: Head of Quality Assurance/Operations**

**Job highlights**
- Ensure standardization of working standards and conduct, as well as preventive maintenance, calibration, and qualification of laboratory instruments as and when required

**Job description**

Implement new testing methodologies and technologies to enhance the accuracy and efficiency of QC processes.

Maintain and ensure the proper functioning of all chemical instrumentation and microbiological testing equipment.

Prepare for and participate in regulatory audits, ensuring all documentation and testing records are compliant with local and international guidelines (e.g., FDA, WHO, GMP).

Implement corrective and preventive actions (CAPA) in response to any deviations or non-conformances.

Prepare for and participate in regulatory audits, ensuring all documentation and testing records are compliant with local and international guidelines (e.g., FDA, WHO, GMP).

Lead and mentor the Quality Control team for injectible products, ensuring optimal performance and adherence to industry standards.

Analyze Finished Product / Stability / Validation / In-process / Swab Samples as per approved specification and standard test procedures.

Recording the analytical data in raw data sheet/protocol.

Foster a culture of continuous improvement and ensure team members are up to date on the latest QC practices and techniques.

Perform and oversee chemical and microbiological testing of injectable products to ensure they meet sterility, potency, and safety standards.

Ensure that all quality control procedures, documentation, and testing records are accurately maintained and in compliance with regulatory standards.

Prepare detailed reports on QC testing, findings, and compliance status for internal and external stakeholders

Lead the calibration, validation, and routine maintenance of lab equipment to ensure accurate testing results.
- **Regulatory Compliance**:

- Ensure all products meet regulatory requirements from the Maharashtra Government and other relevant bodies.
- Prepare for and participate in regulatory audits, ensuring all documentation and testing records are compliant with local and international guidelines (e.g., FDA, WHO, GMP).
- Implement corrective and preventive actions (CAPA) in response to any deviations or non-conformances.

Pay: ₹800,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental Pay:

- Yearly bonus

Work Location: In person

Expected Start Date: 01/12/2024



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