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Patheon
Manager, Validation RR#2017-117
Toronto - Canada
Posted December 05, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

Manages the validation staff to meet customer and client requirements and provides standards and direction to the TRO site and clients in meeting Good Manufacturing Practices (GMP) requirements in the area of Validation.  Interacts with various departments within Operations and Pharmaceutical Development Services (PDS) to resolve validation issues, ensures proper documentation, and completes all validation documentation to meet the Manufacturing Production Schedule (MPS).  Additional duties include Deviation Report (DR) inputs, client or vendor validation protocols and reports approval.

 

 

Key Requirements
  • Strategic thinking – seek and bring ideas with regards to automation, industry bench mark and Regulatory guidelines to support site growth, efficiency and compliance.

  • Supports Corporate validation activities such as DI and CPV.

  • Participates in strategy meetings with other departments to develop Validation guidelines for Patheon.

  • Plans and implements all validation projects for the department.

  • Reviews Validation protocols and creates/updates Standard Operating Procedures (SOPs) for the department.

  • Acts as the liaison between Patheon and the client company regarding validation issues.

  • Schedules and manages day-to-day activities in the department as wells prepares and circulates departmental activity reports and schedules.

  • Coordinates validation activities with other departments to insure project completion and timeliness.

  • Provides input in the preparation of project proposals and budgets for validation activities.

  • Supervises and evaluates subordinate employees. Recommend changes in staffing and budgets as needed.

  • Provides input in investigations and attend meetings discussing commercial processes with ongoing problems.

  • Selects, develops and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures.

  • Lead, mentor and coach Validation staff.

  • Other duties as required.

Qualifications
  • Minimum Bachelor of Science (B.Sc.) Chemistry, Engineering, or other related university in science-related field.

  • Minimum 5 years Industry Experience Quality Assurance, Regulatory, Validation or Manufacturing.

  • Working knowledge of pharmaceutical drug development processes.

  • Excellent written and oral communication skills.

  • Ability to prioritize multiple tasks.

  • Detail-oriented.

  • Proficiency with the English language.

  • Demonstrated commitment to our fundamental principles of Respect, Excellence & Integrity.

Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon Inc. is an equal opportunity employer and is committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. Accommodations for job applicants with disabilities are available upon request.

 
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