Regulatory Compliance Specialist for Pharmaceutical Manufacturing

3 days ago

Old Toronto, Canada Voyant Beauty Full time
Job Description

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Voyant Beauty.

About the Role

This is a critical position that requires expertise in cleaning validation concepts, technical writing, and project management. As a Regulatory Compliance Specialist, you will be responsible for ensuring compliance with FDA, HC, and ICH guidelines. Your primary focus will be on validating manufacturing processes, equipment, and systems to ensure their accuracy and reliability.

Duties and Responsibilities

The successful candidate will be responsible for:

  • Reviewing and assessing impact of changes to validation status for cleaning, manufacturing, and filling processes and equipment using appropriate change control procedures
  • Preparing and maintaining cleaning validation matrices and evaluating products to be validated via Cleaning Assessment
  • Completing yearly summary reports for Purified, Potable, and RO Water, Compressed Air, and HVAC Systems
  • Scheduling and coordinating all validations activities by constant communication with affected departments and personnel
  • Providing training on validation protocols and requirements
  • Ensuring all validation documentation is approved prior to execution
Qualifications and Requirements

To be considered for this role, you must have:

  • A University Degree in Science or Engineering
  • Excellent written and oral English and strong technical writing skills
  • Demonstrated knowledge of cleaning validation concepts
  • Proven organizational, risk management, problem-solving, and project and time management skills demonstrated by previous work experience
  • Knowledge of FDA, HC, and ICH validation guidelines
  • Good knowledge and experience with Microsoft Word and Excel
  • Minimum of 2 years experience in pharmaceutical or related industry
Salary and Benefits

We offer a competitive salary range of $85,000 - $110,000 per annum, depending on experience. You will also enjoy a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

Please submit your application, including your resume and cover letter, to apply for this exciting opportunity.

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