Quality Control Microbiologist
IP Pharmaceuticals India Pvt. Ltd.
Experience: 5 - 10 Years
Compensation: As per the Industry Standards
Education: UG - B.Sc - Microbiology PG - M.Sc - Microbiology
Role: Microbiologist
Job Description
Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Assess bulk drug substance and in-process production records, drug product and finished product records as well as QC test data, deviations, and change controls.
• Review documentation for compliance with cGMP's, FDA, ICH and other regulatory requirements.
• Interact and coordinate with contract manufacturers for documentation requirements.
• Perform quality control activities in order to determine acceptability to appropriate standards, guidelines and conformance criteria specified in procedures, work instructions, protocols and product finished) specifications.
• Evaluate microbial test results of USP Purified Water system, Pure Steam and WFI system, Clean Compressed Air system, and environmental monitoring of cleanrooms.
• Conduct trending and report on investigations to support corrective/preventive action and non-conformance resolutions for microbiological results of environmental monitoring, raw materials, in-process, and finished product testing.
Desired Candidate Profile
Requires a BS degree in microbiology and minimum 5-10 years of relevant experience in the pharmaceutical quality operations environment or a MS degree and minimum 5 years of relevant experience
Strong written and oral communication skills
Must be highly organized with attention to detail and capable of multi-tasking and used to a fast pace environment
Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of various factors
Ability to exercise judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Working knowledge of cGMPs, pharmacopoeial, and regulatory requirements for testing and validation and of current industry trends is required.
Must be proficient at performing microbiological testing such as LAL, Bioburden, Sterility, and Growth Promotion studies etc. according to USP and AAMI
Company Profile
IP Pharmaceutical India is a wholly owned subsidiary of InnoPharma, LLC, a privately held pharmaceutical research and development (R&D) company, based in Piscataway, New Jersey that was founded in 2005.
Website: http://www.innopharmallc.com
Executive Name: Arun Puri
Address: 317-19, Raheja Chambers, No.12, Museum Road, BANGALORE, Karnataka, India 560001
Telephone: 91-80-4907-0000
Reference ID: IP-QCM-001
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