Analytical Technical Steward

Eli Lilly And Company

1 - 5 years

8 - 12 Lacs

hyderabad

Posted:-1 days ago| Platform:

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Skills Required

analytical pharmacy healthcare biochemistry sem manager quality control thermal analysis gmp continuous improvement hplc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization.
Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
Develop investigational testing protocols and perform testing as required.
Contribute to APR, tech transfer, and process validation as required.
Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners.
Participate in internal/external audits as needed.
Develop and ensure execution of quality plan projects.
Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed.
Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices).
Review of analytical test method packages.
Approval of test method protocols.
Approval of new test methods or changes or deletions to existing test methods.
Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions).
Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies.
Improve assays in QC. These improvements include variability reduction, method optimization, and new method development.
Local and Global Method Change Control Ownership.
Oversight of reference standard evaluations per Global Quality Standards.
Selection of appropriate packaging materials.
Consult in the preparation of the characterization protocol for corporate reference standards.
Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards.
Participate in the review of the reference standard profile and associated documentation for data integrity and technical assessment
Oversee transfer and validations of analytical methods for marketed products to CM laboratories or to designated third party QC labs.
Monograph review and implementation.
Ensures consistent practices between laboratories running the same methods.
Effective management of multiple projects.
Oversight of laboratory data integrity compliance at contract manufacturers, use of effective influence to ensure appropriate compliance.

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