Microbiology Lab/ Qc Executive

16 hours ago

Silvassa, India Ami Polymer Pvt. Ltd Full time

Assist in method validation for sterility, bioburden, and endotoxin of Medical devices, drug and Polymer-based products

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Perform and/or assist in Investigations related to sterility assurance and environmental monitoring.
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Perform routine analysis of the finished product and raw material according to established specifications and procedures relating to Sterility, Bioburden, Endotoxin, Antimicrobial Effectiveness Testing (AET) / Preservative Efficacy Testing (PET) and Growth Promotion.
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Perform atypical particulate inspection on the finished product
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Support sampling and microbiological testing on facility water (WFI, CS, etc.)
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Review and approve data related to sterility, bioburden, AET, and endotoxin testing of finished products and/or raw materials.
Perform technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls, and traceability are in place to maintain integrity.
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Prepare and review the preparation of media, reagents, test samples, and equipment as required.
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Prepare microorganisms for identification. Understand and demonstrate the aseptic technique
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Maintain laboratory cleanliness and inventory of microbiology supplies
Familiar with GXP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice)
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Assist with environmental monitoring and microbiological trend reports.
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Prepare and update SOPs of the Microbiology Lab as per the regulatory guidelines Having experience in GLP environment and expertise in documentation work of all the documents as per regulatory requirements.
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Serves as Microbiological lead in multidisciplinary project teams and/or sub-team meetings within the company
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Develop, qualify, and validate assays/ methods with minimum supervision, and write SOPs needed.
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Analyse experimental data with appropriate statistical tools and report scientific results
Interpret data and adhere to strict guidelines on documentation when recording data.

**Job Types**: Full-time, Permanent

Pay: ₹200,000.00 - ₹500,000.00 per year

**Benefits**:

- Food provided
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift
- Monday to Friday
- Weekend availability

Supplemental Pay:

- Performance bonus
- Shift allowance
- Yearly bonus

Application Question(s):

- How many years of experience you have in method validation for sterility, bioburden, and endotoxin of Medical devices, drug and Polymer-based products?

**Experience**:

- total work: 2 years (required)

Work Location: In person

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