Asst. Manager - Microbiologist

Quality HR Services

8 - 10 years

9 - 10 Lacs

vapi

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Skills Required

sterility assurance microbiology glp gmp quality assurance injectables capa equipment qualification usfda data validation ipqa documentation auditing internal audit change control process validation qms sterile mhra media fill

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Participate in management review meetings.
Review of department trend analysis reports and internal studies or investigations.
Ensure corrective action is initiated when required.
Provide complete analysis of test results, investigation or information studies.
Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis.
Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assurance.
Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the Lan and insure implementation within the department.
Maintain thorough knowledge and understanding of regulatory requirements pertaining to microbiology and sterility assurance testing.
Play a lead role in the review and approval for appropriate department SOPs, protocols, and data forms.
Ensure equipment maintenance and calibration performed within the department meets the calibration/maintenance schedule.
Take a lead role in validating new equipment or testing procedures.
Regularly attend meetings and seminars to stay current with industry practice.

Required Skills

Have good communication skills.
Logical Thinking
Organizing

Required Qualification: - M.sc -Microbiology

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