Project Description

  • Shift:  Day

  • Type of position:  Full Time

  • Type of job : Permanent

  • Posting date : 2019-10-29

  • Requisition : 140

  • Category :  Professional

We are currently seeking for a Validation Specialist:

The Validation Specialist is responsible for writing protocols, executing them and writing reports related to the plant’s performance qualification activities including cleaning, sterilization (steam, dry heat, filtration, and irradiation), decontamination, sealing integrity and equipment. It offers its expertise and support to its customers, mainly production.

  • Write and execute the validation protocols under his responsibility;
  • Write risk analysis (or statistical analysis) as part of validation activities;
  • Write and keep up to date the master validation plan related to the expertise of the validation specialist;
  • Write validation reports and other related documents;
  • Investigate deviations in validation protocols, identify the root cause of the deviation, issue corrective and preventive actions, and carry out follow-up once the actions are implemented to ensure their effectiveness;
  • Offer expertise to other departments of the company such as Production, Maintenance, Quality, Engineering and Analytical Services;
  • Participate as an expert in internal audits organized by the Quality group and external audits by the regulatory agencies;
  • Participate in off-site testing for the purchase of new equipment for production or validation (ex: Factory Acceptance Test);
  • Participate in the integration, training and evaluation (i.e. qualification for manual viewing and use of technical equipment) of new employees within the validation or other departments of the company. For example: data acquisition and oxygen analyzer;
  • Participate in the change control process;
  • Participate in the process of reviewing procedures related to validation activities and related activities;
  • Plan and coordinate the activities required as part of the validation protocol with the departments of Production, Maintenance, Quality, Engineering and Stability;
  • Coordinate chemical, physical and microbiological analysis according to the validation protocol (preparation of analysis requisitions, monitoring of analysis with the internal / external laboratory, etc.);
  • Coordinate and / or perform the sampling required by the protocols;
  • Prepare equipment required for validation studies (ex: biological indicators, thermocouples, test samples, test solution, etc.);
  • Meet and communicate with external service providers (ex: laboratory analysis, validation equipment).
  • Bachelor’s degree in chemistry, biochemistry or engineering;
  • Three (3) to five (5) years of experience in validation and pharmaceutical production;
  • Knowledge of GMP’s;
  • Experience in injectable products, an asset;
  • Autonomy, Sense of organization. Results and quality oriented;
  • Excellent level of French and English, spoken and written.
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