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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Recruitment Services |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Job Description The Lab Analyst I is responsible for executing cleaning development studies within the biopharmaceutical and pharmaceutical industries. Working within a project team, you will develop test methods and help identify solutions to optimize our clients cleaning processes. ResponsibilitiesPerform laboratory studies of varying scope and complexity related to cleaning process development. This includes evaluation of residues, screening of cleaning agents, and optimization of critical cleaning variables using design of experiments (DOE) methodologies. Perform method development and assist in method validation using rinse and swab sampling methodology. Generate formalized test plans based on templates and client input to clearly identify the intent and methodology of the studies. Analyze experimental data using standardized tools to support conclusions made by the technical resource. Review data entry and raw data. Generate final reports based on templates to summarize the details and results of the study, including conclusions and recommendations. Take direction from the project manager and technical resource assigned to the project. Execute studies with minimal good documentation practice (GDP) and good laboratory practice (GLP) errors. Adhere to all laboratory policies and procedures. Adhere to all corporate and laboratory safety policies. Adhere to internal quality systems and procedures. QualificationsMust have: Strong verbal and written communication skills, including presentation of data. The ability to work on multiple projects concurrently. The ability to execute according to assigned project priority in order to meet project timelines. The ability to perform individually and in teams. Strong computer knowledge including Microsoft Office products. Familiarity with basic statistics and statistical analysis packages. A willingness to travel. Hands- on analytical laboratory experience. A BS degree in chemistry, biochemistry, or other science related field Preferred: Working knowledge of FDA/ ICH guidelines, applicable regulations, and standards routinely used in the pharmaceutical industry. Knowledge of instrument qualification and operation, especially of equipment commonly associated with cleaning studies (ex. TOC, conductivity, pH, bioburden, and endotoxin testing) . Conversant with general operation of TOC instruments and chromatography. Conversant with HPLC, SDS PAGE, Total Residual Proteins. Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors in the pharmaceutical and biopharmaceutical industries, resulting in the successful construction, commissioning and validation of facilities and equipment. As a member of the Hyde team, you will be responsible for providing state- of- the- art custom solutions to leaders in our industry. As we continue to grow our operations globally, we strive to hire the best talent men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits. You will find the following values reflected in our FamilyIntegrityRespectWisdomAdventure Hyde Engineering + Consulting is an equal opportunity, affirmative action employer. ,
Keyskills :
calibrationqualitycontrolsafetyinspectionisodesignofexperimentsdataentryprojectteamsqualitysystemsmicrosoftofficemethodvalidationlabmethoddevelopmentaffirmativeactiondevelopmentysafety