Test Lead

TechDigital Group; Boca Raton (FL); On-site; Full time

Job summary

An established industry player is seeking a Test Lead with extensive experience in GxP systems validation. This role involves managing testing teams and ensuring compliance with regulatory requirements while utilizing both Agile and Waterfall methodologies. The successful candidate will be responsible for authoring Validation Plans, conducting risk assessments, and overseeing the entire validation testing life cycle. This position offers the opportunity to work in a dynamic environment where your expertise will directly impact the quality and compliance of critical applications. If you are passionate about quality assurance and compliance in the pharma domain, this is the perfect role for you.

Qualifications

• 12 years' experience in validating GxP related applications.
• Expertise in end-to-end validation and compliance analysis.

Responsibilities

• Lead testing teams through the entire validation testing life cycle.
• Ensure compliance with regulatory requirements and customer SOPs.

Skills

Test Management

GxP Systems Testing

Good Communication Skills

Agile Methodology

Waterfall Methodology

Tools

ALM

Job description

Job Responsibilities:

• Test Management in Pharma domain
• GxP Systems Testing and Validation
• Test Design/Execution/RTM in ALM
• Good Communication skills for Customer Interactions

Qualifications:

• 12 years' experience in validating systems and experience in GxP related applications.
• Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs.
• Expertise on end-to-end validation of GxP applications and able to perform document/process compliance analysis.
• Adept with Agile and Waterfall methodology.
• Requirement specifications, functional specifications/user stories/acceptance criteria and ensures completeness of test script with traceability.
• Ensures risk assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements.
• As an onsite Test Lead managing testing teams on the entire validation testing life cycle including test planning, test case design, test execution, and defect management activities.
• Able to author Validation Plan and compile Validation Summary Report, generating RTM reviews, and ensuring that the operational procedure for the application is ready.
• Able to handle change requirement related implementation for small changes.