Quality Assurance Specialist - Pharmaceutical (GMP)

Coppell, TX 75019

Posted: 04/15/2019 Industry: Other Area(s) Job Number: 34814

Quality Assurance Specialist -  Pharmaceutical (GMP)

The Quality Assurance Specialist will be responsible for supporting the Quality Assurance Department in the review of facilities and engineering calibrations, commissioning / validation protocols, final reports for GMP manufacturing and clean utility systems.

1. Provide quality review of commissioning, qualification, and process validation protocols, analyze collected data against pre-determined criteria, and review final reports in compliance with relevant regulations, industry practices and policies and procedures.

2. Review GMP equipment and processes and identify potential critical parameters based upon possible impact on product quality attributes.

3. Review and approval of User Requirements Specifications (URS' s) and Design Qualifications (DQ’ s).

4. Review field verifications of equipment, instruments, and facilities.

5. Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation.

  6. Review of change controls to ensure that equipment, products, processes, and facilities remain in qualified, validated state

7. Identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions

8. Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP

Required:

• Bachelor’ s degree in a science, technical, or engineering field.

•? Five (5) years in pharmaceutical or related industry. The engineer should have knowledge of project execution in a GMP environment.

• Demonstrated understanding of process design, qualification and validation concepts, including the capability to assess processes, equipment, and products for sources of variation, ability to analyze data against predefined criteria and reach appropriate conclusions.

 • Must have attention to detail. Work requires a high degree of accuracy in complex documentation

 • Experience with API processes is preferred.

 • Must understand concepts of qualification and validation as well as sampling, risk evaluation, and detection of variation.

 • Awareness of qualification of control systems and computer system validation (CSV) preferred

• Working knowledge of cGMP and other applicable guidelines and regulations.
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