Valeant Pharmaceuticals

Senior Quality Engineer

US-SC-Greenville
Job ID
9643
Category
R&D
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The role of Sr. Quality Engineer is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Engineer is involved in all stages of the product life cycle --- Product design, manufacturing support, and post-launch maintenance.

 

 

Responsibilities

  • Ensures that new products are properly integrated into the existing quality system.
  • Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. 
  • Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
  • Supports/leads investigations and corrective action efforts. 
  • Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation.
  • Evaluates complaint trends to drive improvements, assisting in their investigation as necessary.
  • Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions.
  • Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls by using relevant statistical tools to analyze data for proactive improvements.
  • Provides routine analysis of performance indicators.  Presents this information to management, supervisors, and manufacturing operators. 
  • Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria
  • Role has no budget responsibility for department spending
  • Responsibility is limited to Greenville Location

Key Relationships:

  • Internal customers/partners: Operations,  Distribution, Commercial, Planning, Compliance, Engineering 
  • External customers: Regulatory Agencies and Notified Bodies

Qualifications

  • Four-year college degree (BA/BS) in fields such as life, physical sciences, or engineering
  • Certifications preferred: CQA, CQE, CQM
  • 5+ years Quality experience
  • 3 years minimum in medical devices or pharmaceutical manufacturing
  • Strong verbal and written communication skills
  • Ability to manage multiple priorities
  • Working knowledge of 21CFR820, 21CFR210/211, ISO 13485, ISO 9001, Quality tools, and problem solving tools, statistical analysis
  • Experience in leading, conducting and writing investigations

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

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