Validation Manager

Our client is one of the world’s leading manufacturers and marketers of quality skincare, makeup, fragrance and hair care products.

Currently, we are seeking a Validation Manager to join the team: 

• Working location: Markham
• Permanent role
• Competitive Compensation Package

POSITION SUMMARY

To ensure that the validation activities are conducted according to the applicable validation policies and procedures and are compliant with applicable regulations across the Canadian sites. Validation activities include Process Validation, Equipment/Facility/Utility Qualification, and Cleaning Validation. Provide key support to the Site Leadership Team for all validation requirements. Assist the site in key compliance activities and responsibilities as described below. Act as a resource for the site in understanding validation and CGMP, implementing them in a practical way, maintaining and improving compliance and facilitating successful site audits by Regulatory Agencies.

KEY ROLES & RESPONSIBILITIES

• Develop/revise validation procedures/protocols as related to equipment to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirements and current industry practices.
• Develop and execute Installation Qualification (IQ) and Operation Qualification (OQ) protocols for equipment used in the manufacture of OTC drug products.
• Develop and execute Process Performance Qualification protocols for existing and new products.
• Identify, document and investigate protocol deviations in conjunction with cross-functional teams, as required to resolve and closeout deviations.
• Organize and coordinate the required activities, including communication with Production, Maintenance, and Quality teams to support and execute IQ, OQ, PQ, and PPQ Validation protocols.
• Write validation summary reports for IQOQ, PQ and PPQ completed studies and ensure the validation documentation is complete, compiled and organized including hardcopy storage and updating central electronic files.
• Develop validation procedures/protocols for site utility products is manufactured in accordance with appropriate regulatory agency validation requirements and current industry practices.
• Maintains all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems.
• Lead cross-functional project teams to assure all validation activities are fulfilled in accordance with site validation plans/project timelines.
• Develop and maintain a thorough knowledge of Canadian and international GMP requirements as they relate to cosmetic production. Acts as an expert resource for the organization on regulatory requirements/trends as they relate to validation activities.
• Evaluate proposed changes to validated systems/processes to ensure changes are managed in accordance with current corporate and regulatory requirements.
• Support quality compliance leads in any visits, audits or contacts with regulatory agencies.
• Act as an SME for the design of new equipment.
• Work with other sites to ensure that good practices are shared and reapplied, consult with other QA organizations to share and reapply good practices.

SKILLS / QUALIFICATIONS

• Education: B.S. Degree in Engineering or scientific discipline
• Years of Experience: 5 years validation experience in a cGMP environment preferably in a pharmaceutical or manufacturing environment
• Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols.
• Must be proficient in validation protocol development, data analysis and report writing. As well as manufacturing/inspection procedures.
• Proven ability to manage multiple priorities and make sound decisions in a fast-paced and changing environment.
• Demonstrated interpersonal skills including strong negotiation and facilitation skills.
• Ability to problem-solve and conduct root cause analysis.
• Proven ability to work and through with key plant functional groups without direct authority.

How to Apply: 

Please send your resume to careers@gc-employment.com  with the subject "Validation Team Lead"

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We thank all applicants for their interest, however, only those selected for further consideration will be contacted.
We are dedicated to building a workforce that reflects the diversity of our customers and the communities in which we live and serve. If you require accommodation throughout the hiring process, please let us know and we will work with you to meet your needs.