The Validation Manager will provide senior level support to the validation operations. They will ensure adherence to all facility SOPs relating to current Health Canada regulations, GMPs, and other applicable regulations. This Manager will be responsible for overseeing all record maintenance of validations and qualifications; as well as, ensuring that quality standards are met in the preparation and execution of these processes. This role will report to the VP, Quality and Regulatory. 

DUTIES: 

• Review and approve selection, purchasing, commissioning, qualification and validation documentation of equipment, utilities, facility and processes with the focus on GMP compliance 
  • Examples are but not limited to: URS, DQ, FDS, FAT/SAT documents/commissioning documents, IQ, OQ, PQ, Validation plan, Risk assessment, validation summary report, SOPs 
• Review and approve deviation/non-conformance/change control/CAPA (events) reports and records from validation/qualification perspective 
• Lead and direct staff by providing validation expertise for issue resolution to support deviations or CAPAs 
• Support Facilities and Transfer Tech Manager to set up a preventive maintenance and calibration program to ensure compliance with GMP requirements and perform QA oversight on calibration and maintenance activities 
• Act as Subject Matter Expert during regulatory and third-party audits 
• Oversee and support the setup and maintenance of validation programs and activities including – process, method, cleaning, transportation, and computer system validation, including the development of validation protocols for novel equipment 
• Design and implement process and cleaning procedures for new product and manufacturing equipment, lead enhancements 
• Track and report on validation performance metrics of projects 
• Establish a high-performing team of validation experts and lead the development of guidelines, tools and competencies based on internal know how, industry best practices and current regulatory guidance 
• Establish and maintain a culture of learning and continuous improvement through capturing lessons learned and enabling cross-project collaboration 
• Establish performance goals and strategic/operational objectives for direct reports 
• Coach, counsel, and appraise performance of personnel 
• Ensures and enforces Good Documentation Practices on all applicable documents relating to GMPs
• Complete all other tasks related to the position, as assigned by the VP, Quality and Regulatory 

QUALIFICATIONS: 

• Bachelor of Science Degree (BSc) in Chemistry, Biochemistry, Pharmacology, Pharmacy, Microbiology, Chemical Engineering or relevant field required 
• 5+ years relevant validation work experience required
• 5 + years of supervisory experience required
• Proven knowledge and experience in applying the risk-based approach throughout the validation lifecycle
• Strong knowledge of GMP and QMS principles
• Strong knowledge of MS Word, Excel and Outlook 
• Excellent analytical skills and above average attention to detail
• Excellent time management and prioritization skills
• Excellent communication skills, both written and verbal.
• Successful completion of Criminal Record Check required

 

If your experience and skill set aligns with the above please submit your resume to careers@dev-valens-australia.pantheonsite.io with subject line ‘Validation Manager’.