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Covance QA Technical Specialist in INDIANAPOLIS, 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)

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

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