Quality Validation Engineer

Morgan McKinley; Tipperary; On-site; EUR 34,000 - 55,000; Full time

Job summary

We are seeking a Quality Validation Specialist to join a Pharmaceutical Company in Tipperary on a 12-month hourly rate contract. The role covers validation master plans, qualification activities, and collaboration with manufacturing teams to ensure timely completion.

You will prepare and review SOPs on Cleaning Validation, risk assessments, and studies related to equipment, processes, and facilities. A background in pharma or medical devices and strong project management and communication skills

Qualifications

• Minimum 3+ years experience in Quality Validation with a background in Pharmaceuticals or Medical Device.
• Bachelor's Degree in Engineering or a related technical field.
• Strong project management skills.
• Strong communication skills.

Responsibilities

• Preparation and review of Validation Master Plan and Project Validation Plans and closure reports.
• Execution, review and approval of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities as QA Validation.
• Coordinate with manufacturing personnel for Qualification / Validation / Re-qualification activity for timely completion of activities.
• Preparation and review of SOPs related to Cleaning Validation.
• Preparation, review, execution, and approval of studies / risk assessments / related to Equipment / Process / Facility / System as QA Validation.
• Procurement and qualification of QA equipment as required.
• Carry out activities as per Head of Department instructions.
• In absence of the employee named above, the designated QA Validation person is responsible for day-to-day activities/duties.

Skills

Quality Validation

Project management

Communication skills

Education

Bachelor's Degree in Engineering

Job description

We are looking for a Quality Validation Specialist to join a Pharmaceutical Company in Tipperary. This is a 12 month hourly rate contract position.

Requirements:

• Responsible for preparation and review of Validation Master Plan and Project Validation Plans and closure reports.
• Responsible for execution, review and approval of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities as QA Validation.
• Responsible to co-ordinate with manufacturing personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
• Responsible for preparation and review of SOPs related to Cleaning Validation.
• Responsible for preparation, review, execution, and approval of studies / risk assessments / related to Equipment / Process / Facility / System as QA Validation.
• Responsible for procurement and qualification of QA equipment as required.
• Activities other than those defined in the job description are to be carried out, as per the requirement of Head of Department and by following Head of Department’s (or approved deputy) instructions.
• In absence of the employee named above, the designated QA Validation person is responsible for day-to-day activities/duties.

Skill, Attributes, Experience:

• Minimum 3+ years experience in Quality Validation with a background in Pharmaceuticals or Medical Device.
• Bachelor's Degree in Engineering or a related technical field.
• Strong project management skills.
• Strong communication skills.