Cleaning Validation Specialist

3 weeks ago


Bowmanville East, Canada ALTEN Canada - Toronto division Full time

Location: Whitby, ON (Onsite)

Job Description:
Evaluate manufacturing process documents or equipment cleaning procedures that must be subjected to validation, in order to acquire information for the definition of the protocols and the execution of the process and the cleaning validation of the procedures. Ensure periodic cleaning verification, as per SOPs and regulatory requirements.
Draft of Validation Protocols (cleaning, Process, Media Fill), by acquiring information from other departments to define their contents (e.g. process parameters, sampling plan) as well as collaborating with company functions to define actions to be carried out, as per company procedures. Handle periodic cleaning validation. Ensure the drafting and/or updating of risk assessments for management of Cross Contamination .
Validate the manufacturing processes and cleaning procedures, collaborating with other departments in the operational activities envisaged by the Protocols. S upport, in conjunction with other functions, in the drafting and approval of documents relating to new products in the transfer and validation phase . Handle deviations related to validation activities if necessary.
Ensure accurate execution of validation activities, through the accurate collection and accurate analysis of the results generated
Draft the Validation Reports , based on the results emerging from the validation activities.
Ensure the accurate archiving of all documentation
Provide quality support for the transfer of new products, through accurate participation in the various phases of the project up process performance qualification, assuring accurate GMP standards in force.
Work on the floor in order to Anticipate any Investigation

Requirement:
Past experience on the field (in Cleaning Validation)
Preferred past experience working on solid doses (ideally former experience with Thermo Fisher Mississauga or Apotex)
Good to have experience with SOPs



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