Specialist, Validation

Job purpose

The Validation Specialist is responsible to lead validation activities and provide expertise for the generation, execution, modification and summation of Validation documents of equipment (manufacturing and laboratory), processes, cleaning, sanitizing and facilities aspects of SunPharma Canada’s manufacturing site that may affect the quality of the product produced or tested.  This is accomplished through interaction and co-ordination of activities with all relevant departments within the organization.

Duties and responsibilities

• Ensure validation programs are established and maintained and provides feedback to generate accurate lists to ensure Master Plan objectives and schedules are met working within the constraints established by the production schedule.
• Prepare Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process).  Ensure protocols provide:
  • A high degree of assurance that a specific equipment or process will consistently produce a product meeting predetermined specifications and attributes,
  • Assurance of the establishment of controls required by current Good Manufacturing Practices (cGMP).
• Responsible and accountable for the execution of Validation Protocols including:
  • Observation and documentation of the equipment or process,
  • Collection of samples,
  • Coordination of testing,
  • Coordination of third party services
  • Write reports that summarize and assess impact of the results generated through the Validation Protocols. Where required, recommend corrective measure(s) with the objective of attaining validated status.
  • Evaluate new equipment from a validation perspective through participation on the equipment selection team with engineering to ensure that new purchases will be capable of meeting validation requirements.
  • Write & revise Validation related SOP’s or Policies make suggestion for improvement of current SOPs as required.
  • Assist in planning Validation program schedules.
  • Train SunPharma Canada personnel on validation related SOPs as required
  • Establish strong relationships inter- and intra-departmentally and provide leadership and guidance.
  • Maintain Validation documentation archive ensuring prompt document retrieval when required.
  • Prepare reports on Validation activities or Pharmaceutical Technology studies as required
  • Complete all GMP Documentation correctly and in a timely manner
  • Complete all training assignments and maintain personal training records
  • Participate in and/or lead Non Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • Participate in Internal, Customer and Regulatory Audits.
• Other duties as assigned

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Bachelor’s degree in Natural Science or Engineering (mechanical or chemical preferred).
• Minimum 5 years of pharmaceutical or relevant technical experience, including experience in at minimum two of the following; cleaning, facility, and/or process validation programs.
• Minimum 3 years’ experience with Installation, Operational and Performance Qualifications.
• High caliber verbal and written communication, including technical report writing ability and project management foundations are required to manage assigned Validation projects effectively.
• Computer literacy, and broad technical knowledge and ability to understand and analyze technical systems (mechanical, electrical & scientific) is required in order to provide value-added input into the Protocol development and execution process.
• Knowledge of the principles and application of current Good Manufacturing Practices guidelines related to Validation activities is essential, as is the ability to work both independently and in a team to achieve objectives.
• Schedule and prioritize workload to meet Validation Master Plan requirements and apply resource in the most productive and efficient manner.
• Source cost effective testing equipment as required to meet protocol commitments.
• Interact with relevant departments to assemble necessary documentation to support Validation activities.
• Takes an innovative approach to problem solving and project planning while ensuring compliance of activities.
• Assess impact of system changes (e.g., modify process) and recommend additional validation testing as necessary.
• Evaluate third party service providers for Validation activities as required.
• Create new or revise testing procedures to satisfy Protocol requirements.

Working conditions

• Variety of working environments including all areas of the office and plant. 
• Occasional exposure to chemicals and higher or lower than normal temperatures. 
• On occasion flexible hours of work may be required to support Validation Protocol execution. 
• Some lifting may be required. 
• Routinely a mixture of standing/walking/sitting are required.

Physical requirements

Office based – 5 days on-site

Direct reports

NA