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For your reference, we have included the original job posting below.
GxP Computerized System Specialist
Job Number:
43879302
Company Name:
Kelly Services
Job Location:
Philadelphia, PA US
Job Category:
Information Technology
GxP Computerized System Specialist
Kelly IT Resources has a full time GxP Computerized System Specialist position available for a client of ours in NorthEast Philadelphia. Please review the job description below and let's talk:
Summary The GxP Computerized System Specialist will assist in providing GxP compliance oversight, support and guidance for the validation of GxP computerized systems. The position will also support the Periodic Review program, approve validation deliverables and change controls related to GxP systems. Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards. Essential Duties and Responsibilities
Conduct periodic reviews of GxP computerized systems
Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
Provide technical expertise, interpretation and direction to management and user in regards to Computer Validation, federal regulations and other quality requirements.
Participate in Impact assessment and approve change controls for company wide cGxP validated systems to ensure systems remain in a validated state.
Perform compliance and risk assessments of computerized systems.
Effectively interact with laboratory, manufacturing, IT, and outside vendors.
Experience validating Enterprise Applications, Lab Systems, Clinical Systems and Automated manufacturing systems.
Participate in GxP related vendor audits.
Participate in improving and maintaining quality systems by authoring governing documents and participating on project teams.
Experience in project management.
Must participate and successfully complete all training as required by the company.
Perform other duties as assigned.
Education/Experience Required
Bachelors degree in Computer Science, Chemistry, Life Sciences or Engineering or related field
4 or more years with hands-on experience in validating regulated systems in a pharmaceutical environment.
Minimum 2 year experience in Quality Assurance.
Knowledge of and experience with any of the following; LIMS, EDMS, ERP, CDAS.
Knowledge of GxP requirements.
Knowledge of computer network and system security principles.
Strong attention to detail.
Specific knowledge of computer validation methodologies, software development life cycles, extensive knowledge of cGMPs, 21 CFR Part 11, Part 820 Quality System Regulation , requirements and ICH guidelines; the ability to review written protocols, specifications, validation documents and other related documents for GxP computerized systems that assure compliance with existing and applicable controls and specifications.
Ability to work independently and in partnership with others.
Proficient in the use of Microsoft Office and other applications as applicable, plus the ability to learn company used applications as required.
Excellent written and oral communication skill, good decision making skills and time management skills.
About Kelly IT Resources Kelly IT Resources (KITR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Launched in 1999, KITR provides information technology specialists across all IT disciplines, including operating systems, programming languages, database administration, application development, website design and development, networks, e-commerce, ERP development, software engineering, and project management. Visit .
