Computer System Validation Consultant

  •  

Kalamazoo, MI

Industry: Software

  •  

5 - 7 years

Posted 358 days ago

  by    Saurabh Saxena

Job Title: Computer System Validation Engineer

Location : Kalamazoo MI

Essential Skills:

·        Experience in MES Validation

·        Very good experience is SDLC and Computer Systems Validation (CSV)

·        Agile Methodology experiencepreferred

·        Supply chain experiencepreferred. Experienceworking withSAP ECC preferable.

·        InfrastructureQualificationexperience

·        Experience in creation/maintenance & implementation of SOPs

·        Experience in the use of HP Quality Center and similar tools to manage software testing and requirements.

·        Worked in cGMP, 21 CFR Part11 and GAMP 5 environment? Hands on authoring/ review/ approval of computer system validation deliverable, inclusive of requirements gathering. Functional specification, test/validation plans, protocols, test scripts / cases, tractability matrix and summaries

Role Description:

·        Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies

·        Review functional design specification, technical design specifications for clarity, Good documentation practices.

·        Review the accuracy and completeness of software validation deliverables created by process work streams

·        Knowledge of software testing. Ability to create Traceability Matrices linking approved requirements to test cases within HPALM.

·        Create validation deliverables like Requirements, Data Migration Plan, Summary Reports, work instruction documents for tools

·        Ability to pull necessary details from an object level Technical Design Specs and Functional Design specs and consolidate the information in a Master Technical and Functional Design document that is presentable to an external regulatory agency.

·        Experience working in an agile environment is preferred

·        Keep the Program Validation Lead/Validation Project Manager informed of any issues regarding the quality of deliverables or any potential sources of impact to the project timeline.

·        Report on the status of validation deliverables and supportother compliance work as necessary

Desirable Skills:

·        High level knowledge working with HPALM

·        Experience with MS Office applications.

·        Experience working in a cross functional system and within scrum teams.

·        Experience in Software validation and compliance activities in Pharma (GMP) environment

·        Experience in working with GxP applications

Competencies:

·        Domain : LS - Regulatory IT Compliance ( CSV, ERES Compliance)

Keywords:

·        SAP Validation, Regulatory and Compliance, Validation, MES

$80K - $90K