Multiple Requirement:: Validation Consultant & Change Control Specialist
Manish Gupta
Role : Validation Consultant
Work Location : Kalamazoo, MI
Duration of assignment (in Months) : 12 months
Relevant Experience(in Yrs) : 5-8 Years
Rate: $40/hr
Technical /Functional Skills
• Very good experience is SDLC and Computer Systems Validation (CSV)
• Agile Methodology experience preferred
• Supply chain experience preferred. Experience working with SAP ECC preferable.
• Infrastructure Qualification experience
• 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
• 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 deliverables, inclusive of requirements gathering. Functional specification, test/validation plans, protocols, test scripts / cases, traceability matrix and summaries
Roles & Responsibilities
• 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 support other compliance work as necessary
Generic Managerial Skills
• Very good communication skill with strong customer relationship management skills
• Proactive and Innovative.
• Good analytical skills. Should be able to evaluate a situation and take right decisions.
• Should be able to own the activities and drive for completion.
• Capabilities to host meetings, capability of handling multiple projects, multiple stakeholders and Conflict resolution.
Urgent Requirement: Change Control Specialist (SC, $30)
Role : Change Control Specialist
Work Location : Greenville, SC
Duration of assignment (in Months) : 12 months
Relevant Experience(in Yrs) : 1-2 Years
RATE: $30/hr
Experience Required
• Minimum 3-year experience in Change Control management
• Familiar with software & Microsoft office
Roles & Responsibilities
• To support in the change control process in Product life cycle management tool, to interact with stakeholders and deploy necessary solutions.
• Capture all the contract scope, project requirements in PLM including CLIN dates, PRS etc.
• Coordinate with engineering teams to meet the customer deliverables and properly capturing the customer issues/queries/concerns and get them resolved with engineering team through defined processes in PLM.
Generic Managerial Skills:
Excellent communication skill (verbal and writing)
Strong Cross functional team skills