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Piramal Pharma Ltd · 1 month ago

Analytical Scientist

Riverview, MI

Full-time

Onsite

Mid, Senior Level

0+ years exp

Piramal Pharma Ltd is a leading company in the pharmaceutical sector, seeking an Analytical Scientist to join their Analytical Chemistry team. The role involves developing and validating analytical methods, primarily HPLC and GC, to support quality control and manufacturing operations.

BiotechnologyConsumer GoodsHealth CareManufacturingPharmaceutical

Responsibilities

Develop analytical methods that are accurate, precise, and specific for use in both the Quality Control department and the Process Development department. Methods primarily include HPLC and GC but may extend to other testing procedures

Document the development of the method in the appropriate notebooks for future reference

Prepare PPS-Riverview test methods and supporting documentation for use in the laboratory

Validate analytical methods used in the testing of raw materials, intermediate products, final products, and cleaning samples

Develop validation protocols to assess the necessary features of the test methods. Assesse all data elements required for assay validation as per the current USP and other regulatory requirements. Perform protocols as written and documents the results in the form of a comprehensive validation report and makes any necessary changes to existing documents as a result of report findings

Assist in the maintenance and calibration of laboratory analytical instrumentation including, but not limited to HPLC and GC. Maintain accurate records regarding the maintenance and calibration activities

Support manufacturing operations with testing of raw materials, intermediate products, final products, and cleaning samples. The incumbent is expected to operate in a neat and orderly manner and to provide accurate and timely test results

Assist in the maintenance of the QC Laboratory. In addition to routine housekeeping and glassware cleaning, maintains and appropriate inventory of supplies and chemicals

Document sample preparation, equipment set-up and test results in Laboratory Notebooks or on the appropriate test record form. Documentation must be complete and verified by a second member of the quality group. In addition, laboratory log sheets, those related to equipment usage, calibration, and maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples will be properly maintained

Partake in the rotating weekend on-call schedule to support the plant’s 24/7 operations

Qualification

HPLCGCAnalytical testingAnalytical instrumentationMicrosoft Office SuiteAnalytical skillsOrganizational skillsCommunication skillsAttention to detail

Required

Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices

Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values

Identify and protect the original technical information as part of the company property

Develop analytical methods that are accurate, precise, and specific for use in both the Quality Control department and the Process Development department

Document the development of the method in the appropriate notebooks for future reference

Prepare PPS-Riverview test methods and supporting documentation for use in the laboratory

Validate analytical methods used in the testing of raw materials, intermediate products, final products, and cleaning samples

Develop validation protocols to assess the necessary features of the test methods

Assess all data elements required for assay validation as per the current USP and other regulatory requirements

Perform protocols as written and document the results in the form of a comprehensive validation report

Make any necessary changes to existing documents as a result of report findings

Assist in the maintenance and calibration of laboratory analytical instrumentation including, but not limited to HPLC and GC

Maintain accurate records regarding the maintenance and calibration activities

Support manufacturing operations with testing of raw materials, intermediate products, final products, and cleaning samples

Operate in a neat and orderly manner and provide accurate and timely test results

Assist in the maintenance of the QC Laboratory

Document sample preparation, equipment set-up and test results in Laboratory Notebooks or on the appropriate test record form

Documentation must be complete and verified by a second member of the quality group

Maintain laboratory log sheets related to equipment usage, calibration, and maintenance

Partake in the rotating weekend on-call schedule to support the plant's 24/7 operations

Ph.D. in Chemistry or Biochemistry and 0-3 years' experience; OR

Master's Degree and 3-5 years' experience; OR

Bachelor's Degree and 5-10 years' experience in a related environment

Knowledge of analytical testing and instrumentation

Excellent organizational and planning skills

Strong written, verbal, and interpersonal communication skills

High attention to detail

Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines

Proficiency with Microsoft Office Suite and industry-related software (Agilent ChemStation, etc.)

Company

Piramal Pharma Ltd

Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through its 17 global facilities, which include end-to-end development and manufacturing capabilities, and a distribution network in over 100 countries.

Founded in 2020

Mumbai, Maharashtra, IND

10001+ employees