Senior Manager Microbiology
About GlenmarkThe company has a significant presence in branded generics markets across emerging economies including India.
Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business.
The subsidiary also markets APIs to regulated and semi-regulated countries.
Glenmark employs nearly 8000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide, Glenmark is well placed on the road of growth and is exceedingly well prepared to take the completion head-on.
The Microbiology Sr.
Manager reports to the Director, Microbiology.
The primary responsibilities are to manage and coordinate staff performing microbiological testing, support the manufacturing of aseptically process and terminally sterilized pharmaceutical products.
Provides technical leadership, daily oversight and subject matter expertise as needed to manage the QC microbiology laboratory functions:
Microbiological testing of raw-materials, in-process materials and finished products.
Developing and validating microbial test methods for bioburden, sterility, liquid particle counts and endotoxin tests.
Reading, review and trend analysis of environmental monitoring and water test data.
Contamination Control Strategy, Media Fills, Qualification for sterilizers.
In this role you will be the primary contact for the microbiology laboratory, collaborating with personnel outside of the department, facilitating timely and right the first time data management and reporting and assuring testing is completed in support of manufacturing timelines and regulatory standards.
EducationBachelor degree in Pharmaceutical Sciences, Microbiology or equivalent required.
Masters degree in microbiology or equivalent, preferredExperience 5 7 years in the field of Pharmaceutical (formulation facility).
Background of functions of Microbiology.
Experience of working with Injectable facility.
Experience working with Audits Knowledge and SkillsKnowledge of cGMP, validations and qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, handling of regulatory inspections, well acquaintance with QMS, well versed with change control/deviations and market complaint management system.
Leadership/Managerial Attributes:
Capable to lead team, good communications skills, front runner, GMP trainer Recommended Skills Auditing Certified Global Meeting Planner Change Control Claim Processing Communication Data Management Estimated Salary: $20 to $28 per hour based on qualifications.
Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business.
The subsidiary also markets APIs to regulated and semi-regulated countries.
Glenmark employs nearly 8000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide, Glenmark is well placed on the road of growth and is exceedingly well prepared to take the completion head-on.
The Microbiology Sr.
Manager reports to the Director, Microbiology.
The primary responsibilities are to manage and coordinate staff performing microbiological testing, support the manufacturing of aseptically process and terminally sterilized pharmaceutical products.
Provides technical leadership, daily oversight and subject matter expertise as needed to manage the QC microbiology laboratory functions:
Microbiological testing of raw-materials, in-process materials and finished products.
Developing and validating microbial test methods for bioburden, sterility, liquid particle counts and endotoxin tests.
Reading, review and trend analysis of environmental monitoring and water test data.
Contamination Control Strategy, Media Fills, Qualification for sterilizers.
In this role you will be the primary contact for the microbiology laboratory, collaborating with personnel outside of the department, facilitating timely and right the first time data management and reporting and assuring testing is completed in support of manufacturing timelines and regulatory standards.
EducationBachelor degree in Pharmaceutical Sciences, Microbiology or equivalent required.
Masters degree in microbiology or equivalent, preferredExperience 5 7 years in the field of Pharmaceutical (formulation facility).
Background of functions of Microbiology.
Experience of working with Injectable facility.
Experience working with Audits Knowledge and SkillsKnowledge of cGMP, validations and qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, handling of regulatory inspections, well acquaintance with QMS, well versed with change control/deviations and market complaint management system.
Leadership/Managerial Attributes:
Capable to lead team, good communications skills, front runner, GMP trainer Recommended Skills Auditing Certified Global Meeting Planner Change Control Claim Processing Communication Data Management Estimated Salary: $20 to $28 per hour based on qualifications.
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