Located in Barrie, Ontario, MediPharm Labs (TSX: LABS) offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, named Start-Up of the Year at the most recent Canadian Cannabis Awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.Job Summary: The Validation Lead will be responsible for defining and creating validation processes for all existing and new equipment, ensuring the processes are in line with best practice and evolving regulatory expectations.  Responsibilities:Lead our validation program, examining current validation processes and recommending process improvements including developing, documenting, and implementing protocols and proceduresScript and oversee Analytical Methods Validations as requiredWork closely with all departments ensuring the operation of a validated environment according to GMP and other regulatory requirementsOrganize documentation and local execution of method transfersDefine, support and guide validation activities both internally and for external suppliersProvide product validation guidance relating to activities needed for new product launchesProvide validation and technical direction to lead project teams as neededDevelop/review and approve validation protocols and final reports and ensure compliance with cGMPs and current regulatory requirementsCoordinate and manage hold-time studies, cleaning studies, and revalidation/qualification activities for the siteDrive best practices toward continued or continuous process validation (CPV)Train colleagues in validation best practices and health authority expectationsPartner with manufacturing, QA, and technical transfer teams to resolve all deviations encountered during project and protocol executionCreate and write validation protocols, directives, SOPs, and reports as required and review for technical validityReview change requests for impact to validation and support QA compliance activities such as Product Quality ReviewSkills & Qualifications:Experience in a pharmaceutical/manufacturing environment, along with a relevant science degreeThorough knowledge and understanding of validation requirements in a cGMP facility and Validation Lifecycle ApproachCompetent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standardsStrong communication skills, including the ability to present to senior managementDemonstrated experience in building relationships and using influence. Can establish credibility and earn respect with a diverse set of internal and external stakeholders including manufacturing partners and other functional managersAbility to "get things done" without compromising principles.A high level of energy and strong work ethic is critical to successMediPharm Labs is committed to providing accommodation for applicants with disabilities in its recruitment processes. If you require accommodation at any time during the recruitment process, please contact 705-719-7425 ext. 223

Validation Lead

Located in Barrie, Ontario, MediPharm Labs (TSX: LABS) offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, named Start-Up of the Year at the most recent Canadian Cannabis Awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.

Job Summary:

The Validation Lead will be responsible for defining and creating validation processes for all existing and new equipment, ensuring the processes are in line with best practice and evolving regulatory expectations.  

Responsibilities:

  • Lead our validation program, examining current validation processes and recommending process improvements including developing, documenting, and implementing protocols and procedures
  • Script and oversee Analytical Methods Validations as required
  • Work closely with all departments ensuring the operation of a validated environment according to GMP and other regulatory requirements
  • Organize documentation and local execution of method transfers
  • Define, support and guide validation activities both internally and for external suppliers
  • Provide product validation guidance relating to activities needed for new product launches
  • Provide validation and technical direction to lead project teams as needed
  • Develop/review and approve validation protocols and final reports and ensure compliance with cGMPs and current regulatory requirements
  • Coordinate and manage hold-time studies, cleaning studies, and revalidation/qualification activities for the site
  • Drive best practices toward continued or continuous process validation (CPV)
  • Train colleagues in validation best practices and health authority expectations
  • Partner with manufacturing, QA, and technical transfer teams to resolve all deviations encountered during project and protocol execution
  • Create and write validation protocols, directives, SOPs, and reports as required and review for technical validity
  • Review change requests for impact to validation and support QA compliance activities such as Product Quality Review

Skills & Qualifications:

  • Experience in a pharmaceutical/manufacturing environment, along with a relevant science degree
  • Thorough knowledge and understanding of validation requirements in a cGMP facility and Validation Lifecycle Approach
  • Competent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standards
  • Strong communication skills, including the ability to present to senior management
  • Demonstrated experience in building relationships and using influence. Can establish credibility and earn respect with a diverse set of internal and external stakeholders including manufacturing partners and other functional managers
  • Ability to "get things done" without compromising principles.
  • A high level of energy and strong work ethic is critical to success

MediPharm Labs is committed to providing accommodation for applicants with disabilities in its recruitment processes. If you require accommodation at any time during the recruitment process, please contact 705-719-7425 ext. 223

To apply online, please click on the appropriate link below.