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Compliance Specialist

  • Location: New Brunswick
  • Job Type:Contract

Posted 13 days ago

  • Expiry Date: 04 June 2022

Job Description:

Responsibilities:

  • Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and requirements.

  • Carries out functions of the GxP-ITQA as directed including but not limited to:

  • Review and approval of key computer system Validation Life Cycle (VLC) deliverables;

  • Review and approval of test scripts and defects associated with computer system validation;

  • Oversight of key Software Development Life Cycle (SDLC) process such as incident, problem, change, release, etc.;

  • Ensure adequate and timely regulatory compliance support.

  • Partner with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.

  • Provide backup support for the department as needed and perform other assignments as required.

  • Support internal and external (regulatory) inspection activities related to validated systems.

  • Provide support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.

  • Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.

  • Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.

Qualifications:

  • Experience in the BioTech/Pharmaceutical industry or similar regulated industry required;

  • Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes;

  • Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance

  • Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements;

  • FDA 21 CFR 11, EU GMP Annex 11 and GAMP 5 standards;

  • Data Integrity Guidance;

  • In-depth understanding of industry-accepted software development and validation life cycle programs and related IT controls;

  • Experience with relevant GxP systems such as quality management systems, document management systems, ERP, training/learning management systems, clinical and laboratory systems preferred;

  • Understanding of quality risk-management concepts (ICH Q9) preferred;

  • Understanding of ITIL Framework concepts (e.g., Incident, Problem, Change management processes)

  • Understanding of Good Documentation Practices.

  • Project management practices and techniques;

  • Experience with automated testing practices and tools preferred;

  • Computer hardware, software including MS Office and MS Project;

  • External and internal inspections support a plus;

  • Excellent analytical, interpersonal, and communication skills, including written and verbal communication.

Education:

  • Bachelors degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.