Location: Aiken,SC, USA
HTI is seeking a Deviation Analyst for PAI Pharma, a large manufacturer of prescription and OTC pharmaceuticals. Leveraging cutting-edge technology to produce the best-in-class suspensions and oral solutions, this manufacturer has been recognized for being a leader in innovation,quality, and safety. Understanding it is their employees who make the true impact, this organization is known for their commitment to being an employer of choice - offering competitive pay, benefits, and a positive environment for employees at any level!
What They Offer:
What You Need:
What Your Role Will Look Like:
The Deviation Specialist thoroughly investigates deviations that arise in various aspects of the company, including Manufacturing, Quality Control, and Facilities, using problem-solving tools such as root cause analysis to assist with identification of appropriate corrective actions to prevent recurrence. Collaborates with various departments to gather information, evaluate causal factors, and implement appropriate CAPAs, based on root causes identified in deviation. Ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to deviation investigations, deviation initiation, and related CAPAs. Facilitates cross-functional meetings and provides guidance and consultation to the deviation/CAPA process owners and makes recommendations to continuously improve processes.
Investigation and Compliance:
Root Cause Analysis and Evidence Gathering:
Reporting and Trend Analysis:
Skills and Abilities:
About HTI
Human Technologies, Inc. (HTI) has been a trusted partner since 1999, collaborating with leading companies to deliver tailored solutions for workforce management, development, and retention. HTI is an Equal Opportunity Employer M/D/F/V/SO.