Previous Job
Previous
Q/A Validation Pharmaceutical
Ref No.: 17-01629
Location: Devens, Massachusetts
Position Type:Contract
Start Date / End Date: 12/12/2017 to 06/11/2018
Q/A VALIDATION PHARMACEUTICAL
DEVENS, MA


Project Description:
  • Perform the QA review/approval of analytical documentation:
    • Analytical method validation protocols and reports for in-process and release/stability testing.
    • Analytical method procedures and associated change controls.
    • Method technical transfer protocols and reports.
    • Reference Standard and Critical Reagent qualification protocols and reports.
    • Certificates of Analysis for reference materials and critical reagents.
    • Standard Operating Procedures and other guidance documents.
  • Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications.
  • Collaborate with manufacturing support functions to develop the methods and acceptance criteria for the development of raw material specifications in preparation for Process Performance Qualification activities.

Required Skills:
  • Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials.
  • Experience with the review and approval of method validation protocols and reports.
  • Experience collaborating with technical teams to develop validation strategies that are compliant to regulatory guidance and Client policies.
  • Experience collaborating with technical subject matter experts to resolve validation protocol or report compliance gaps and indicate if technical gaps are present with the overall validation strategy.
  • Experience collaborating with technical subject matter experts to resolve protocol deviations and investigations.


This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01629
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE