Quality Assurance Executive Microbiologis

3 weeks ago


Sonipat, India Siora Surgicals Full time

**Number of Openings**: 01

**Experience**: Minimum 02 Years

**Salary**: 25K -30K

**Functional Area **:Quality Assurance

**Industry**: Medical Devices/ Equipment

**Employment Type**: Permanent Job, Full Time

**Job Location**: Plot No. 1792, HSIIDC, Industrial Estate, Rai, District - Sonipat, Haryana.

**Education**: (UG) B. Sc in Microbiology
**- Performing Bioburden and Sterility tests for medical devices as per ISO 11737 Part-1 and Part-2 respectively.
- Environmental Monitoring by plate exposure, contact plate and swabbing method
- Handling, Calibration, and maintenance of equipment’s along with maintenance of subsequently generated records.
- Monitoring stability and shelf-life study of products
- Preparation of validation protocol for all the instruments in microbiology lab.
- Maintenance & revival of required pure mother cultures.
- Generating test report for bioburden & sterility tests respectively.
- Develop & perform microbial method validations
- Develop & perform validation protocol and report for autoclave.
- Test efficacy of media & chemicals.
- Technical justification of all the test method deviations being made performance of test activities.
- Ensuring authenticity & checking of all the data being generated in performance of test activities.
- Implement ISO 13485:2016 compliance throughout the whole company.
- Develop and maintain standard operating procedure (SOP) for all the department.
- Facilitate internal audit & MRM and preparing reports accordingly.
- Prepare technical file as per different countries requirements.
- Ensuring the integrity & confidentiality of all the data being generated in the company.

**Company Profile**:
One of the Leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and having manufacturing unit at Rai Industrial Area, District Sonipat, Haryana and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.



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