***Quality Assurance Officer/Specialist-Tipperary***
QA Officer required for a leading pharma organisation in Tipperary.
Overview of Main Responsibilities (full job description available on request):
- Originating, Approving and Issuing Production Documentation (Manufacturing & Packaging)
- Originating, Approving and Issuing Standard Operating Procedures (SOP's), in compliance with cGMP requirements
- Reviewing SOP's, as per review schedule
- Issuing Stability Documentation, approval of testing protocols, review of stability report
- Reviewing Validation protocols & validation reports (including process validation, cleaning validation and equipment validation protocols and reports)
- Reviewing Product Development Documents
- Internal and external auditing.
- Investigating and review of deviations and out of specification results
- Investigating customer complaints
- Proofing and approval of artwork
- Review Batch Documentation
- Change control , vendor certification and approval of suppliers, raw material review
- CAPA reports
What the ideal candidate looks like:
- Educated Degree level – Chemistry, Pharmacy or Biological Science. with experience within the pharmaceutical industry, preferably within QC or QA or appropriate experience.
- Ability to leverage/collaborate effectively with internal and external stakeholders
What you will get in return:
- Competitive Salary
For a confidential discussion and more information on the role, please contact Aisling Lane.