Valeant Pharmaceuticals

Quality Specialist

Job Location US-CA-Petaluma
Job ID
9863
Pos. Category
Quality

Overview

Valeant Pharmaceuticals International, Inc. is a diverse 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 Quality Assurance Specialist I/II provides Quality support for site activities involving pharmaceutical product development.  The role ensures that quality systems and projects are managed in compliance with cGMP standards and applicable FDA regulations, as well as company policies and procedures.

Responsibilities

  • Review and approve specifications (API, raw material, drug product), ensuring conformance with applicable monographs and pharmacopeia testing standards.
  • Review and approve validation protocols and reports.
  • Review and approve stability protocols and data tables.
  • Review and approve equipment qualification protocols and deliverables, as well as calibration data.
  • Audit analytical laboratory raw data.
  • Understand technical procedures and be able to verify accuracy of calculations.
  • Review and approve production records.
  • Review and approve non-conformance investigations.
  • Perform internal audits.
  • Ensure timeliness and integrity of work.
  • Provide support for site audits and regulatory inspections.

Qualifications

  • Bachelor’s Degree in a scientific or related discipline with 2-5 years pharmaceutical industry experience in a GMP environment.
  • Knowledge of the Code of Federal Regulations, particularly 21 CFR Parts 210 & 211.
  • Knowledge of basic microbiology, chemistry or laboratory operations.
  • Experience implementing, maintaining and improving quality systems, including SOP writing.
  • Strong communication and collaboration skills, as well as the ability to work effectively with minimal supervision

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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