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, with emphasis on process equipment and critical utilities (including Compressed air systems).
- 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.
