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Validation - Compliance Specialist

In New Jersey / United States

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Validation - Compliance Specialist   

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JOB TITLE:

Validation - Compliance Specialist

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

New Brunswick New Jersey / United States

JOB DESCRIPTION:

Responsibilities:

  • Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.
  • Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.
  • Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.
  • Ensures compliance with all Company policies and procedures, including safety rules and regulations.
  • Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
  • Performs related duties as assigned.

Requirement:

  • Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience
  • 21CFR11/ EU GMP Annex 11 and GAMP 5 standards
  • Data Integrity Guidance
  • Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
  • Project management practices and techniques
  • Software development life cycle
  • Computer hardware and software applications including Quality related computer systems, MS Office and MS Project
  • Principles and practices of computer compliance, validation and qualification
  • Knowledge of automated testing practices and tools a plus
  • External and internal inspections
  • Stakeholder management in a cross-functional organization
  • Reviewing user, functional and design specifications.
  • Reviewing and executing protocols and test scripts
  • Sampling, testing and measuring techniques.
  • Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
  • Selecting, training, supervising and evaluating departmental personnel
  • Managing multiple projects, duties and tasks,
  • Communicating clearly and concisely, both orally and in writing.
  • Establishing and maintaining effective working relationships with those contacted in the course of work.

Position Details

POSTED:

Jun 23, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204865172463807

LOCATION:

New Jersey / United States

CITY:

New Brunswick

Job Origin:

CEIPAL_ORGANIC_FEED

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Validation - Compliance Specialist    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Responsibilities:

  • Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.
  • Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.
  • Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.
  • Ensures compliance with all Company policies and procedures, including safety rules and regulations.
  • Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
  • Performs related duties as assigned.

Requirement:

  • Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience
  • 21CFR11/ EU GMP Annex 11 and GAMP 5 standards
  • Data Integrity Guidance
  • Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
  • Project management practices and techniques
  • Software development life cycle
  • Computer hardware and software applications including Quality related computer systems, MS Office and MS Project
  • Principles and practices of computer compliance, validation and qualification
  • Knowledge of automated testing practices and tools a plus
  • External and internal inspections
  • Stakeholder management in a cross-functional organization
  • Reviewing user, functional and design specifications.
  • Reviewing and executing protocols and test scripts
  • Sampling, testing and measuring techniques.
  • Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
  • Selecting, training, supervising and evaluating departmental personnel
  • Managing multiple projects, duties and tasks,
  • Communicating clearly and concisely, both orally and in writing.
  • Establishing and maintaining effective working relationships with those contacted in the course of work.


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