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
