PQ Authoring and Execution (Freelance)

Provides PQ planning, authorship, dry run testing and supports formal PQ testing period by providing support to end users.

• Author PQ scripts and PQ test-protocols for execution of the performance qualification as part of the validation of the complaint module in Trackwise and within a pre-determined time frame. This includes working with the Philips Business Process Expert (BPE) to review the outline of test cases associated with a release. Based on the testing outline, and following the Philips PQ protocol and script development procedures, develop protocols and test scripts and enter into the ValGenesis tool. Route the protocols and scripts for approval in the ValGenesis tool.
• Evaluate existing protocols and scripts, based on the testing outline, to determine if new scripts are necessary or if existing scripts need modification.
• Support the dry run of the PQ protocols and scripts by verifying the accuracy and quality of the protocols and scripts.
• Support the execution of the PQ test-protocols within the pre-determined timeframe. Supporting execution includes reviewing exceptions when needed, working with the tester to help understand the script and making corrections to the protocols and scripts to include routing for approval within the pre-determined timeframe.
• Person should be detailed oriented, familiar with medical device complaint handling processes and software validation of supporting complaint handling tools.
• Person should be a self-starter, having some project management skills associated with organizing their work, contributing to and meeting project management schedules.

Experience:

1-2 years of experience writing PQ test scripts and testing PQ test scripts in a medical, pharmaceutical or healthcare industry

Philips experience (preferred but not required)

Education:

Associates or bachelors degree preferred but not required (degree in either English, software engineering, business)

Knowledge of the TrackWise system (preferred but not required)

Certifications in medical device regulatory standards (preferred but not required)