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Validation Specialist

Cambridge

Apresentação da empresa

Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.

Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.
We have an opportunity for a Validation Specialist.

Descrição da vaga

The Validation Specialist is accountable to the Validation Manager for all activities relating to the coordination and performing of validation activities, including protocol generation, execution and closure in accordance with the requirements of Standard Operating Procedures and Good Manufacturing Practices. This includes leading teams, analyzing data and assessing validation systems.

Informações adicionais

  • Writes validation protocols, including Master Plans; determines required validation testing based on guidelines (HPB & FDA).
  • Audits and approves protocols, drafts and executed reports.
  • Analyzes and reviews validation data and write reports on results.
  • Prioritizes and schedules validation activities. Informs operations scheduling.
  • Manages all validation projects, process cleaning, equipment, and computer systems.
  • Performs designs and writes pre-validation studies.
  • Tracks, maintains & investigates (or designates an investigator) for validation deviations.
  • Designs, reformats validation systems and SOPs.
  • Leads validation teams; execute protocols as part of a team.
  • Follows GMP and regulatory requirements, and ensures quality standards are met.
  • Observes and supports all safety guidelines and regulations.
  • Models the Company Mission, Vision and Values Statements, policies, and current standard business practices.
  • Performs other related duties as required.

Perfil

Education

  • Degree in Engineering (Biochemical, Mechanical, Chemical) or Life Sciences
  • Proficiency in Microsoft Office applications especially MS Project

 Experience

  • A minimum of 2 years’ experience in a pharmaceutical, food or cosmetic manufacturing environment 
  • Quality Assurance background would be an asset
  • Ability to work in a multi-discipline team and work independently.  Ability to manage multiple projects
  • Strong communication and interpersonal skills. French / Portuguese an asset
  • Demonstrates initiative, problem solver and motivated
  • Excellent project management skills
  • Willingness to travel (<10%)