Senior Compliance Expert—Change Control, Deviations, CAPA

Description

100% onsite

Work Schedule: Mon-Fri(normal business hours)

Our major pharmaceutical client needs a Senior Compliance Specialist to manage and provide oversight for their Quality Systems reviews, change control, deviations investigations and CAPA requirements.

Requirements:

Implementation of an improvement to this client s deviation and investigation management process.

Build and create environment moving forward, working directly with onsite deviation teams and help them manage Change Control properly.

Assist with overseeing inefficiencies/deviations, helping to reduce backlog of deviations of their QMS environment.

Perform investigations/execution of the backlog while identifying risk and write up the deviations accordingly.

Drive the change and serve as catalyst for building new habits and ways of working by helping management judge progress, enforce standards, and track progress.

Mentoring and training of helping this client "manage change" in terms of their teams understanding and adopting the improved ways of working. (Not to be mistaken with "managing change control records").

Help off load backlogs into the InfinityQS environment.

Requirements:

Bachelor Degree Engineering/Mechanical or industry related

5-10 years experience with deviation and CAPA management systems in the pharm industry.

Worked with GMP and non GMP environments.

Must be independently thinking consultant who can analyze the investigations/deviations they're managing and have the experience to understand if they are successfully making change or not.

Having worked with QMS environments like Infinity, Trackwise & Veeva. Most preferably InfinityQS.