Search Results

Manager, QA Computer System Validation

Magnolia Recruiting, LOS ANGELES california

This job is no longer available.

Manager, QA Computer System Validation       

Reports to: Director, QA Systems        


Exciting opportunity to join a growing biotechnology company in Los Angeles! This is a permanent role seeking a QA Validation expert with a strong background in GAMP 5 and the pharmaceutical industry. Amazing company culture offering 100% paid healthcare benefits for you and your dependents!


Primary Objective of Position

The QA Validation Manager will primarily support Computerized System Validation (CSV) activities of in-house and vendor hosted (SaaS) systems, administer IT Change Control process.


Major Duties/Responsibilities

  • Administer IT Change Control and process IT Change Requests (ITCRs) to ensure changes are sufficiently assessed, validated and implemented on-time.
  • Work with IT, Company stakeholders and software vendors to provide SDLC support.
  • Provide QA validation oversight for new standalone and enterprise computerized system implementations, including vendor hosted systems.
  • Author validation lifecycle documentation including VP, URS, FRS, DS, TM, VSR, protocols (e.g. IQ, OQ, PQ), and test scripts (e.g. UAT, Regression Testing) and support execution of validation testing.
  • Ensures compliance with applicable regulations, standards and guidance (US FDA/MHRA/EU/ICH) and Company requirements.
  • System release management. Verify pre-release validation or testing requirements are met prior to system “go-live” into Production.
  • Retain validation documentation in the designated EDMS repository, and support archival of QA documentation.
  • Perform data migration qualifications.
  • Perform computer systems risk and impact assessments.
  • Assist in maintaining and updating the computer system inventory list on an ongoing basis.
  • Assist in performing periodic IT systems reviews and assessments. Analyze IT and system related deviations/ incidents, propose corrective actions or issue resolutions.
  • Assist in internal and external IT audits.
  • Support QA departmental goals and initiatives.

 

Skills & Abilities

  • Comprehensive knowledge of GxP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP 5, data integrity standards, SOX compliance, ICH and FDA guidance.
  • Effective written and verbal communication skills, with the ability to communicate clearly and concisely across all internal departments at all levels, and external parties such as vendors and contractors.
  • Strong interpersonal skills, team player, and flexible without compromising quality.
  • Self-motivated and able to effectively prioritize and manage multiple tasks in a fast-paced environment, with the ability to meet expedited timelines.
  • Excellent time and project management skills.

 

Physical Demands

  • Ability to be productive and successful in a busy work environment.
  • Subject to extended periods of sitting, reading, computer work, and moderate noise levels.


Education & Professional Experience

Education

  • Bachelor’s degree in Engineering, Science or related discipline


Experience

  • 5 or more years of relevant Quality and Computerized System Validation (CSV) experience, including GxP computerized system validations and IT change controls.
  • ERP and cloud (SaaS) system validation and IT infrastructure qualification experience a plus.

To get started, enter your information below

I agree to the Flashrecruit terms of use and acknowledge I have read the privacy policy, and agree to receive jobs alerts.