Pharmaceutical Method Validation

MN

Job ID: 122140 Industry: Pharma

 

Pharmaceutical Method Validation

Project Description:

The client is currently in need of bringing on additional consultants to help with their laboratory services department.  They are in need of someone to come on site and act as a SME in technical writing from a lab perspective.  This consultant will be working with method validation and method development protocols and will be responsible for authoring the documents.  They will be working on gap assessments of their raw material vendor technical packages as well.  This consultant will be responsible for reviewing and evaluating analytical methods and validations prior to being transferred to the QC department.

Day to Day Responsibilities:

This role is intended for someone who comes from a very strong laboratory background.  He/she will be responsible for working with the SME’ s in method validation, gathering the information required and then authoring the documents related to method validation/verification and method development/feasibility protocols and reports.  This consultant will be responsible for critically analyzing data in support of the project directives.

The consultant chosen for this role will be reviewing raw material vendor technical packages/DMF’ s and be responsible for conducting a gap assessment.  If gaps do exist, this consultant will provide advice on how to properly remediate the gaps.

This role also entails being responsible for evaluating the analytical methods and validations prior to transferring them to the QC department to ensure that they meet all current requirements. 

Required Skills:

Authoring and reviewing method validation and verification

Author/revise QC documents

Good team working skills

Hands on technical writing experience in the lab.

Small molecule

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