Specialist, Validation (Contract)

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.

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

Working conditions

Physical requirements

Office based – 5 days on-site

Direct reports

NA