Officer/ Executive - Microbiology
1 Nos.
109382
Full Time
4.0 Year(s) To 6.0 Year(s)
Not Disclosed by Recruiter
Production / Quality / Maintenance
Medical Devices & Equipment
B.Tech/B.E. - Other Engineering
Job Description:
- To establish analytical lab procedures, policies and safety regulations
- Maintain laboratory records to ensure accuracy and compliance
- conduct laboratory test, results and documentation
- Assist In method validation for sterility, bioburden, arid endotoxin of Medical devices, drug and Polymer-based products
- Perform and/or assist in Investigations related to sterility assurance and environmental monitoring.
- 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.
- Perform atypical particulate inspection on the finished product
- Support sampling and microbiological testing on facility water (WFI, CS, etc.)
- Review and approve data related to sterility, bloburden, 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.
- Prepare and review the preparation of media, reagents, test samples, and equipment as required.
- Prepare microorganisms for identification.
- Assist in setting up lab
Company Profile
Since 1998, APPL is in the business of Silicone Elastomeric products and also, other Polymeric components which ultimately provide solutions to Fluid Transfers, Sealing, and Contamination controls for Biopharma, Pharma, Medical, Laboratory, Food, Beverages, and Engineering sectors worldwide.
APPL is having ISO Class VII and ISO Class VIII Cleanroom facilities certified with ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, ISO 13485:2016. We also have a BPOG extractables program for our products for regulatory markets worldwide.
The company believes in “Be in business with ethics” and assure Quick Development, Fastest Delivery, Ultimate Quality and also very Competitive Rates.
Telephonic Interview Available
- Telephonic interview are scheduled for this job opening.
- Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
- Candidates can call recruiter on given contact to start telephonic interview during working hours.