Sr Microbiologist, FGO QMS

Gurgaon - India

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

What you will do:

Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards and monitoring of utilities including all grades of water and where necessary compressed air bioburden and entoxin testing.
Review/writing of cleaning protocols and reports in line with ISO 19227 standards
Oversight of EtO sterilization processes. Validation and monitoring in line with ISO 11135
Oversight of radiation sterilization processes. Validation and monitoring in line with ISO 11137
Interpreting sampling and monitoring data appliying statistical and analysis techniques to determine control and trending. Indentifies and initiates when to take action.
Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting correction of NC and root cause analysis.
Act as technical lead for microbiology in cross functional groups including product and process issues rootcausing projects initiatives and other business critical forums..
Review of cleaning and sterilization validation files for compliance.
Strong interactions maintainance and support of sterile finished goods suppliers.
Interact with Supplier quality team with respect to vendor sterilization topics.
Performs sterilization release review intepreting data and trends.
Continually identifies opportunity for stabilization of trends statistical control of processes to allow cost saving.

What you will need:

Bachelor degree Microbiology or equivalent/ related subject required with 6 years Microbiology related experience
Masters of Microbiology or equivalent related subject required with 3 years Microbiology related experience
Experience of 6 years in Quality/Regulatory Affairs environment.
Experience in interacting with regulatory agencies (FDA MoH TUV etc.) required.
Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
Must possess strong communication project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

Travel Percentage: 10%

Required Experience:

Senior IC

Work Flexibility: HybridWhat you will do:Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards and monitoring of utilities including all grades of water and where necessary compressed air bioburden and entoxin testing.Review/writing of cleaning protocols and reports in...

Work Flexibility: Hybrid

What you will do:

Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards and monitoring of utilities including all grades of water and where necessary compressed air bioburden and entoxin testing.
Review/writing of cleaning protocols and reports in line with ISO 19227 standards
Oversight of EtO sterilization processes. Validation and monitoring in line with ISO 11135
Oversight of radiation sterilization processes. Validation and monitoring in line with ISO 11137
Interpreting sampling and monitoring data appliying statistical and analysis techniques to determine control and trending. Indentifies and initiates when to take action.
Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting correction of NC and root cause analysis.
Act as technical lead for microbiology in cross functional groups including product and process issues rootcausing projects initiatives and other business critical forums..
Review of cleaning and sterilization validation files for compliance.
Strong interactions maintainance and support of sterile finished goods suppliers.
Interact with Supplier quality team with respect to vendor sterilization topics.
Performs sterilization release review intepreting data and trends.
Continually identifies opportunity for stabilization of trends statistical control of processes to allow cost saving.

What you will need:

Bachelor degree Microbiology or equivalent/ related subject required with 6 years Microbiology related experience
Masters of Microbiology or equivalent related subject required with 3 years Microbiology related experience
Experience of 6 years in Quality/Regulatory Affairs environment.
Experience in interacting with regulatory agencies (FDA MoH TUV etc.) required.
Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
Must possess strong communication project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

Travel Percentage: 10%

Required Experience:

Senior IC

Key Skills

Laboratory Experience
Aseptic Technique
Virology
Clinical Laboratory Experience
FDA Regulations
Laboratory Procedures
PCR
Microbiology
Quality Control
GLP
cGMP
Laboratory Information Management Systems

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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