QA Validation Specialist

Industry : Pharmaceutical

Role Summary:

QA Validation Specialist to manage and execute the Cleaning Validation / Verification Program for Site.  Oversight of Qualification of Equipment / Computerised Systems / Facilities and Utilities to ensure compliance with regulatory requirements, company policy and procedures.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Management and Execution of the Cleaning Validation / Verification program for Process
    Equipment to ensure no cross contamination on shared equipment.
  • Co-ordinate with Product development to obtain information related to any new product e.g., Equipment required for manufacture, Batch Size, Potency (recommended Daily Dose), Cleanability/ Solubility, Recommended Cleaning Solution, Toxicity (PDE).
  • Preparation of Product Matrix and calculation of MACO (Maximum Allowable Carry- over) for different Inhalation Products.
  • Execution of Studies / risk assessment to identify worst case locations for swabbing.
  • Co-ordinate with Engineering for Equipment Matrix and calculation of Product Contact Surface Area for shared equipment.
  • Preparation of Cleaning Validation Plans and cleaning verification protocols.
  • Oversight of Development of Cleaning Steps for Process Equipment.
  • Establishment of ongoing cleaning programs and improvements e.g. campaign cleaning.
  • Review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities as QA Validation.
  • Generates and executes project validation plans and validation master plans.
  • Participates in any investigations that may impact the qualified state of equipment, systems, facilities, or utilities.

Role Education And Experience:

  • Science Graduate with minimum 5-year experience in QA Validation, including Cleaning
    Validation in the Pharmaceutical Industry.

Contract Duration:  Permanent

Location:  Co Tipperary

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