Job Description :

- Adhering to Good Documentation Practices and Good Laboratory practices.

- Responsible for day to day planning and allocation of microbiology activities.

- Strong in MLT method validations for API, Excipients and Finished products.

- Responsible for Preparation of Validation protocols, summary reports for MLT, BET and sterility method validations.

- Responsible for daily review of all Log books, Analytical raw data documents.

- Responsible for implementation of cleaning procedures in microbiology lab.

- Responsible for imparting SOP training to all team members and contract persons as per requirement.

- Responsible for ensuring of analyst Qualification to the respective personnel.

- Monitoring Quality of water system.

- Management of Stock availabilities of Microbiological consumables and its prequalification.

- Testing abilities on MLT, BET, Sterility, Bioburden, Liquid Borne Particle Count (LBPC), Water analysis, Preservative Efficacy test, Container Closure integrity Test (CCIT), Growth promotion test, and Identification of Microorganisms by Vitek 2 campact.

- Handling of Microbiological Media, Bioballs and biological indicators.

- Media fill (process simulation) validation.

- Environmental monitoring of classified areas by settle plate, Air sampling, Surface monitoring and personnel monitoring and compressed air monitoring.

- Responsible for review of water and environmental monitoring Trends.

- QMS activities: Responsible for Handling of Deviations, Incidents and out of specifications, Out Of trend, CAPA and change control.

- Responsible for reviewing of calibration status of instruments and timely completion as per schedule.

- Preparation of Standard operating procedures, Standard testing procedures and general testing procedures, Specification and its revision as per pharmacopeia requirement.

Salary:INR 4,50,000 - 5,00,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Executive

Employment Type: Permanent Job, Full Time

Keyskills

sterility environmental monitoring water analysis microbiology mlt bet finished products QC Quality Control Formulation

Desired Candidate Profile

Candidates should be working in Pharma Company.

Dealing into Quality Control-Microbiology.

Should be a Male person.

Education-

UG: B.Sc - Any Specialization, B.Pharma - Pharmacy

PG:MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy

Doctorate:Doctorate Not Required

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