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 Senior Quality Assurance Specialist provides support for multi-disciplinary teams engaged in new product development for Pharmaceuticals. The role ensures that quality systems and projects are managed in compliance with global GMP standards, ISO and FDA regulations, and Valeant policies and procedures.
· Work with functional department representatives to ensure product development plans are managed in compliance with GMP standards and relevant global regulations.
· Review and approve GMP documentation, including API and product specifications, analytical and microbiology method validations, development protocols and reports, stability protocols and reports, equipment/facility qualifications, and clinical trial production records.
· Review and approve Master Validation Plans and Validation Strategies for qualification of manufacturing equipment/systems and validation of processes in Valeant manufacturing facilities. Review and approve process validation data.
· Review and approve validation requirements for changes to validated systems/processes.
· Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation.
· Develop and maintain product and process risk management plans and assessments, including design changes.
· Support OOS, OOT, aberrant and invalid result investigations and ensure they are acted upon in a timely manner.
· Conduct statistical analysis and develop plans for sampling of processes. Evaluate key acceptance criteria and critical process parameters.
· Responsible for Change Control and requalification requirements of validated systems.
· Bachelor’s Degree in a scientific or engineering discipline with a minimum of 5 years related work experience in the Pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance, and regulatory requirements.
· Demonstrated knowledge of basic microbiology, chemistry, and other laboratory operations
· Experience working in a fast-paced organization as a member of multi-disciplinary teams.
· Strong communication, collaboration, and decision making skills and ability to work effectively with minimal supervision.
Valeant is an EEO/AA employer M/F/D/V.
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