Compliance Team, Inc.

Validation Consultants

Job Locations US-IL-Oak Brook
Posted Date 5 days ago(2/14/2018 7:49 AM)
ID
2018-1207
# of Openings
1
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 and laboratory equipment systems. We seek top-notch professionals who have diverse project experience in the pharmaceutical or medical device industry.

Responsibilities

  • Maintain documentation in a GMP environment.
  • Develop and execute validation protocols for bulk compounding and filling processes.
  • Develop and execute protocols for laboratory and manufacturing IQ/OQ/PQ.
  • Maintain the company Metrology program, by submitting calibration forms, collecting equipment due for calibration, distributing calibrated equipment, and maintaining asset calibration test data.
  • Provide support for the technical change control function for documenting equipment modifications.

 

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

In addition to the above technical competencies, ideal candidates will have a commitment to deliver quality documents and service. 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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