Part 11 Validation Analyst

Job Description

Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries.  The Validation and Regulatory Compliance division focuses on validation and quality positions within our clients.  We work with skill sets ranging from 21 CFR part 11 compliance, to equipment and process validation.  We understand the unique pressure that comes with working in an FDA regulated environment.


Delta Pharma offers a full range of benefits to our consultants, including Blue Cross/Blue Shield Medical and Vision, Delta Dental, 401K with company match, and Holiday and Vacation pay.  *Relocation assistance may also be available based on the situation.  Become a part of our success story!
 

Pharmaceutical company is currently looking to hire a Part 11 Validation Analyst with experience in the pharmaceutical industry.The IT Quality Systems Analyst analyzes system solutions and documents validation plans and reports.  He/she understands the customer’s business and manages relationships with key customers.  The IT Quality Systems Analyst participates in the delivery of system solutions by assuring validation activities are conducted in a cost effective and compliant manner.  The IT Quality Systems Analyst works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations.


Job Requirements

Essential Job Description:Establishes and maintains relationships with key customers. Analyzes system projects and participates in validation strategy definition. Creates/Reviews validation plans and provides guidance to IT groups for creation of validation deliverables. Provides guidance to the IT organization for user acceptance testing including test strategy, test scripts and trace matrices. Plans and manages the validation activities for medium to large projects. Responsible for the creation/review and approval of User Acceptance Test Scripts, Validation Summary Reports, System Test Scripts, Part 11 Assessments and other SDLC documents as applicable to the project. Works closely and communicates effectively with business customers, other IT groups, management, Software Quality Assurance (SQA) and external vendors to validate system solutions addressing compliance with company policies, work procedures and validation plans.  Works with IT groups, customers, and SQA to identify and resolve problems that occur during computer system validation and implementation. Reviews system and validation documentation for accuracy, correctness and compliance with SOPs and work procedures.  Proactively identifies issues and escalates them appropriately. Performs other duties as assigned.

Education and Experience Required:Bachelors Degree or four years of work  experience in a corporate environment Minimum of 4 years IT  experience with knowledge and experience in gathering requirements, functional design, and working with business processes in the pharmaceutical industry Knowledge of System Development Life Cycle Knowledge of FDA regulations and guidelines is a MUST

Benefits:Blue Cross/Blue Shield Medical and Vision Delta Dental 401k Holiday and Vacation Pay Relocation assistance (*may be available on a case-by-case basis)