- Draft Validation Protocols (e.g. cleaning, process), by acquiring information from other departments to define their requirements (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. Support, 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 collection and analysis of the results generated
- Draft the Validation Reports, based on the results emerging from the validation activities.
- Work on the floor in order to Anticipate any Investigation
- Past experience on the field (in Cleaning Validation)
- Preferred past experience working on solid doses (ideally former experience with Thermo Fisher Mississauga or Apotex)
- Experience with risk based cleaning strategy is an asset
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Cleaning Validation Specialist - Whitby, Canada - ALTEN Canada - Toronto division
Description
Location: Whitby (Onsite)
Job Description:
Requirement: