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QA Technical Specialist

Covance 3/8/2019 1:59:03 PM
JOB ID: 28676 Category: Quality Assurance
Greenfield, Indiana

   

 

Job Overview

We are seeking a QA Techncial Specialist for our Greenfield, IN site. The Computerized Systems Quality Specialist is a role within the QA function, requiring substantial technical and regulatory expertise. The role is responsible for ensuring GxP compliance with regulations and industry standards relating to the management of Computerized Systems and the assurance of data integrity.

The role is specifically involved in:

* The development, implementation and improvement of methodologies aimed at meeting regulatory expectations
* Representing QA on project teams aimed at validating new or upgraded computer system s and instrumentation
* Reviewing and approving key computer system validation deliverables
* Defining and managing inspection program(s) that are operated to assure the compliance of our computerized systems, instrumentation, and electronic records.
* Leads a programme of training relating to compliant Computer System Lifecycle Management and Data Integrity Assurance
* Guiding, advising, arbitrating and influencing the organization on a range of computer system compliance and data integrity matters.
* Conducting specialist audits and audits of suppliers and service providers relating to the development and maintenance of computerized systems
* Providing subject matter expertise during hosted audits by clients and regulatory authorities and subsequent response and follow up of audit observations relating to computer system compliance and data integrity
* Represents Covance on external industry regulatory forums

Education/Qualifications

* Bachelor degree (or equivalent) in Science or Technology related discipline. Experience may be substituted for education in some circumstances.

* Experience working in the Pharmaceutical or related Industry, preferably in a QA/compliance role and fully familiar with Good Practice Reguations (GLP, cGMPs, GCP)
* Working knowledge of regulatory agency guidelines relating to Computerized System Compliance/Data Integrity and Industry Standards, e.g. GAMP5.
* Ability to confidently interact with and influence staff at all levels, clients and regulatory authority representatives.
* Proven organization, observation, and problem solving skills.
* Skilled in written and verbal communication.

Experience

Minimum Required: All candidates would be considered on their own respective merits, but the following is the typical level of Experience held by individuals in this position:

* Minimum of three years in in a regulatory/QA role
* Experience as a Lead Auditor
* Demonstrable Experience of successful client interaction
* External podium presentations at relevant regulatory meetings (preferred)


Position Type: Full-Time

Location: Greenfield, IN - Indiana



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).