Compliance Specialist in Swiftwater, PA at Pyramid Consulting, Inc

Date Posted: 8/7/2020

Job Snapshot

Job Description

Immediate need for a talented 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: 20-22131

Key Requirements and Technology Experience:
  • Assist in organizing the priority task force meetings.
  • Assist in performing the sites evaluation and assessments.
  • Assist in the identification of the necessary remediation for each site.
  • Follow up on action and ensure deliverables are met on time.
  • Alert in case of roadblock or delays.
  • Provide input in validation document reviews.
  • Assist in organizing monthly review meeting with the Validation CoE members.
  • Process validation (biologics / vaccines).
  • Knowledge of Health Authorities environment: Europe, US, Canada, Japan, China, Brazil, Mexico, OMS, .
  • Quality by Design, Control strategy.
  • Quality risk management, FMEA.
  • Project management and Communication
  • Continuous Quality Improvement and Quality Culture..
  • CoE Priorities defined roadmap deliverables.
  • Site assessment and remediation plan.
  • Global documentation.
  • Engineer/master degree, with 5+ 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.