IT Quality Compliance Specialist/Analyst

  • Contractor
  • Full-Time
  • Onsite
  • Splintpharma
  • Prefferd visa: OPT, CPT, F1, H4, Need H1 Visa, EAD
  • Posted 2 months ago – Accepting applications
Job Detail
  • Offerd Salary $ 35 - $ 48
  • Required Position 2-4 hires
  • Experience 0-3 Years Required
Job Description

Job Opening for IT Quality Compliance Specialist/Analyst Client; BMS

We are currently working on below mentioned i., e. Job Opening for IT Quality Compliance Specialist/Analyst Client; BMS. Please let me know if you are interested in applying for the same.

IT Quality Compliance Specialist/Analyst
Client; BMS
Rate: $48/Hour

Onsite position. Candidate is required to report onsite
Prefer candidates with Veeva, Document Management System or QMS along with Job Description expectation.
Manager top 3 skills, please continue to submit resumes with the below:
Pharma Quality Assurance Expertise
CSV Validation skills, Problem Solver
Regulatory Background on 21 CFR Part 11, Annex 11, GAMP5, GMP, GCP

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 BMS requirements.
o 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;
o Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements;
o FDA 21 CFR 11, EU GMP Annex 11 and GAMP 5 standards;
o 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:
• Bachelor’s degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.

Job Requirement

Job Opening for IT Quality Compliance Specialist/Analyst Client; BMS

We are currently working on below mentioned i., e. Job Opening for IT Quality Compliance Specialist/Analyst Client; BMS. Please let me know if you are interested in applying for the same.

IT Quality Compliance Specialist/Analyst
Client; BMS
Rate: $48/Hour

Onsite position. Candidate is required to report onsite
Prefer candidates with Veeva, Document Management System or QMS along with Job Description expectation.
Manager top 3 skills, please continue to submit resumes with the below:
Pharma Quality Assurance Expertise
CSV Validation skills, Problem Solver
Regulatory Background on 21 CFR Part 11, Annex 11, GAMP5, GMP, GCP

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 BMS requirements.
o 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;
o Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements;
o FDA 21 CFR 11, EU GMP Annex 11 and GAMP 5 standards;
o 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:
• Bachelor’s degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.

Required skills