Compliance Team, Inc.

Validation Consultants

US-NC-Raleigh
5 days ago
ID
2017-1191
# of Openings
10
Category
Validation

Overview

Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.

 

We are putting together a team to assist our pharmaceutical client in the commissioning and qualification of facility, utility, process equipment, processes and laboratory equipment, and test methods. We seek top-notch professionals who have diverse project experience in the pharmaceutical or medical device industry.

Responsibilities

  • Write and execute commissioning, qualification, and validation documents
  • Perform characterization/engineering studies as necessary to establish processing parameters necessary for validation testing
  • Initiate change controls to determine impact of changes to facility, utilities, equipment, process/product as applicable, and system owners
  • Investigate and resolve of validation discrepancies during the execution of protocols
  • Collaborate with a team of professionals to establish a complementary team that provides the best value solution to our client

 

Qualifications

  • Minimum of 2 years experience in FDA related manufacturing or laboratory operations
  • Knowledge of FDA regulations, pharmaceutical GMPs
  • Familiar with pharmaceutical manufacturing process, facilities and equipment, calibration, IQ, OQ, PQ, and development of SOPs
  • Experience with process control applications is desirable
  • Excellent communication skills: written, oral and interpersonal,  Technical writing skills are essential
  • Must be willing to travel or reside in the Raleigh area.

In addition to the above technical competencies, ideal candidates will have a commitment to deliver quality documents and service, and be passionate about CTI's commitment to providing clients with the best-cost compliance solution to our clients. Candidates must be results-oriented, able to make decisions and able to prioritize work per business needs.  The successful candidate will demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation..

 



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