Analyst II - IT Quality and Validation Specialist

Duration through 12 31 2012

As a member of the IT Quality & Regulatory Compliance team, the Quality Assurance and Validation Specialist helps to define, plan, and perform duties that support major system development life cycle activities—including validation review and change control approval—of IT systems. These life cycle activities are performed for both custom-developed and commercial, off-the-shelf (COTS) software applications

PRINCIPAL DUTIES & RESPONSIBILITIES:

A. Essential Functions:

•Review and approve IT change control requests submitted by IT project teams.
•Review and approve validation-related deliverables produced by IT project teams.
•Create and review IT system development life cycle (SDLC) templates.
•Consult on the authoring and conformance of validation-related deliverables and activities in regard to corporate SOPs and current regulations.
•Work alongside other validation professionals to gather data, plan activities, and obtain reviews and approvals of documentation.
•Assist in developing functional and technical requirements for IT systems.
•Provide guidance, training, and support to IT personnel in their validation efforts, to ensure compliance.
•Provide guidance, training, and support to IT personnel in the use of Microsoft Word, in relation to validation deliverables.
•Provide GxP-related quality assurance oversight, with an emphasis on software validation.
•Track system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.

B. Additional Functions:

•Provide document development training to less-experienced members of the validation team.
•Represent IT Quality & Regulatory Compliance on cross-functional teams in support of SDLC activities.
•Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
•Provide monthly statistics to management on projects completed, including review and approval of requests for change and validation deliverables.

III. JOB DEMANDS:

This job requires the Quality Assurance and Validation Specialist to attend—either in person or through electronic means—department and user meetings, system assessment meetings, trainings, and other essential tasks. The Quality Assurance and Validation Specialist must maintain a professional manner in representing the company and in working with its agents and associates. The Quality Assurance and Validation Specialist should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.

IV. JOB IMPACT:

The Quality Assurance and Validation Specialist’s role is essential in maintaining systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.

IV. QUALIFICATIONS:

A. Essential:

•Excellent communication skills in standard English, including demonstrable writing skills, speaking, and comprehension
•Strong PC skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications
•Interviewing, research, and analysis skills
•An undergraduate degree in Communications, Technical Writing, Engineering, Biology, Physical Sciences, Computer Sciences, or a related field
•Three or more years of experience in computerized system validation within a regulated environment (GLP preferred)
•Two or more years of experience in quality assurance, technical documentation, software testing, or related auditing
•Two or more years of experience in the pharmaceutical or biotechnology industry, or in a contract research organization (CRO)
•Thorough knowledge of validation principles (including IQ, OQ, and PQ)
•Thorough knowledge of GLP and 21 CFR Part 11 regulations and guidelines
•Detailed knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance
•Knowledge of general software and database concepts
•Knowledge of risk analysis and risk management
•Knowledge of infrastructure technology and platforms
•The ability to work both independently and with teams at various levels in the organization
•Excellent organizational skills and attention to detail and accuracy
•Ability to see a project through to its completion
•Ability to learn new or unfamiliar software applications through research, training, and self-instruction

Warm Regards...

Parijat Bodas

Resource Specialist
DecisionWave Inc.,
Business decisions made easier with Oracle BI
Direct: 617-933-8407 Fax: 866-758-0846
pbodas@decisionwave.com

www.DecisionWave.com 

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