Senior Compliance Specialist in Swiftwater, PA at Pyramid Consulting, Inc

Date Posted: 6/30/2020

Job Snapshot

Job Description

Immediate need for a talented Senior Compliance Specialist with experience in the Pharmaceuticals Industry. This is a 10+ Months Contract opportunity with long-term potential and is located in Swiftwater, PA. Please review the job description below.
Job ID: 20-21641

Key Requirements and Technology Experience:
  • Assist in the definition the initial control and validation strategies, planning the associated activities and ensuring the integration of digital tools and quality oversight.
  • Work with sub-teams involved in validation activities (Quality, Engineering, Manufacturing technology, Data Science, Operation).
  • Facilitate risk analysis sessions for the Validation and Control strategies which will be based on Quality risk management and Quality by design principles.
  • Draft the associated documentation. Interpret complex, explicit documentation to ensure quality standards and compliance.
  • Support the Senior Quality Project Team in case of Health Authorities communication.
  • Critical thinking and innovation thinking are key in the context of the EVF project.
  • May provide training to project team members.
  • Work under only very general supervision.
  • Work is reviewed for soundness of judgment and overall adequacy and accuracy.
  • Process validation (biologics / vaccines).
  • Quality by Design, Control strategy.
  • Quality risk management, FMEA.
  • Project management and Communication.
  • Continuous Quality Improvement and Quality Culture.
  • Validation risk assessement.
  • Control Strategy document.
  • Validation Strategy document.
  • Advances degree or PhD, with 10+ years in quality validation.
  • Risk-based approach / ICHQ9 mindset.
  • Vaccines & Biotech Processes understanding/knowledge.
  • Methodology ability.
  • High level of autonomy.
  • Excellent communication skills, able to manage cross functional communications.
  • Leadership during workshops / Experience in understanding customer's voice and quality requirements is a must.
Our client is a leading Pharmaceuticals Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. 

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