*Send me resumes at [email protected]*
*Role: Validation Lead*
*Location: Chicago, IL*
*Duration: 6+ Months*
*Position Overview: ***
This position is responsible for leading and performing activities in
support of the validation and compliance of a system or application. The
Validation Lead is responsible for monitoring compliance to the CQPs, Baxter
QMS, and other established IT policies/procedures.
1. Leads the Computer Validation activities within a project or
multiple global projects with medium to high complexity.
2. Responsible for creating, managing, and/or maintaining the
documents required for the development and validation of the computerized
system.
a. Create and review all validation documents in the project.
i. Authors
Validation Plan, Training Plan, Issues Log, Design Review, IQ
Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test
Incidents, Trace Matrix, and Validation report.
ii. Reviews Functional
Specifications, Design Specifications, User Manuals, System Procedures,
System Description and Training records.
b. Participates in Supplier selection process, if required.
c. Creates or contributes to the Supplier Audit Report, if required.
d. Contributes to or gathers CSV metrics for reporting purposes.
3. Oversight of protocol execution
a. Manages the overall protocol execution process, including resource
management, scheduling/timeline management, incident management, and status
reporting.
4. Prepares documentation within a validation package per policy and
procedure to support the validation of an application/system.
5. May participate in the development of internal CSV training
materials.
6. May indirectly manage Validation Analysts activities within a
project.
7. Leads or participates in CSV effectiveness and improvement
initiatives.
8. Leads or participates in CSV knowledge development.
Desired skills / certifications / training
1. Minimum of 5-6 years experience in Computer Systems or Software
Validation.
2. Strong knowledge of project development/implementation processes.
3. Ability to make good judgments and quick decisions.
4. Solid presentation skills.
5. Solid oral and written communication skills and teamwork skills.
6. Strong influencing/negotiation skills.
If above details matches your skills / Experience respond towards
[email protected] / 609 945 3178
--
Regards,
Santosh
(609)-945-3178
Ezen Computer Services Inc.,
