Associate, Validation

Job purpose

The primary purpose is to generate, execute, modify and summarize validation documents for equipment, facilities (manufacturing and laboratory), manufacturing processes, cleaning and sanitizing processes at 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

• Write Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process). Ensure protocols provide:

1. a high degree of assurance that a specific equipment or process will consistently produce a product meeting predetermined specifications and attributes,
2. assurance of the establishment of controls required by current Good Manufacturing Practices (cGMP).

• Responsible and accountable for the execution of Validation Protocols including:

1. observation and documentation of the equipment or process,
2. collection of samples,
3. coordination of testing and
4. 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.
• Perform equipment and process validation reviews as required.
• Write or revised Validation related SOP’s or Policies as required.
• 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.
• File and maintain Validation documentation archive ensuring prompt document retrieval when required.
• Manage effectively all assigned Validation projects.
• Establish strong relationships inter- and intra-departmentally.
• Work proactively with other departments to ensure Validation requirements are met.
• Complete all GMP Documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Train SunPharma personnel on protocol execution requirements as necessary.
• Participate in and/or lead Non Conformance Investigations, as necessary
• Complete Corrective and Preventive Actions (CAPA’s)
• Initiate, and follow through with actions required to close Change Controls
• 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 2 years of pharmaceutical or relevant technical experience.
• Strong project management and communication /writing skills
• Proficient computer skills and broad technical knowledge are required in order to provide value-added input into the Protocol development and execution process and to understand and analyze technical systems (mechanical, electrical & scientific).
• 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
• Knowledge of Change Control Systems.
• Exceptional verbal and written communication skills
• Innovative mindset combined with strong problem solving ability.
• Problem Solving:

• The ability to schedule and prioritize workload to meet Validation Master Plan requirements and apply resource in the most productive and efficient manner.
• Interact with relevant departments to assemble necessary documentation to support Validation activities.
• Assess impact of system changes (e.g., modify process) and recommend additional validation testing as necessary.
• Create new or revise testing procedures to satisfy Protocol requirements.

Working conditions

• 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. Some travel to support equipment factory acceptance testing may be required. Routinely a mixture of standing/walking/sitting are required

Physical requirements

Variety of working environments including all areas of the office and plant.