On behalf of our client, a global pharmaceutical company are currently recruiting for a QA Techician role
DUTIES AND TASKS:
- Maintaining the internal CAPA system
- Maintaining the internal Complaint system
- Maintaining the internal SCAR system
- Maintaing the internal change control system.
- Driving actions to closure, providing status updates to management
- Support with supplier approval (Bona Fide) and review
- Maintaining the internal and external audit schedule
- Gathering and organizing findings, issuing reports in preparation for audits
- Providing data for Quarterly and annual Management meetings
- Providing data for manufacture , distibribor meetings
- Provide administrative support for users of the electronic document database
- Upholding the Document Control and Records Management systems.
- Supporting internal departments, manufactures and distributors during new product introductions and requlatory inpsections.
- Managing warehouse and logistics including regular inventory reports
- Assign in generating new SOPs.
- Support Pharmacovigilance, Medico vigilance and Compliance activities as directed when required
- Gather batch release documentation for Quality Manager to review.
- Other ad hoc duties as and when required
Skills & Experience Requirements:
- A degree in a life science or pharmacy discipline.
- 2 years’ work experience in a compliance environment and a good understanding and working knowledge of GDP and ISO 13485
- Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland, EU and US.
- Proficiency in the English language with strong verbal and written communication skills is essential.
- Ability to process technical information.
- Accuracy and excellent attention to detail.
- Excellent organisational skills.
- Good interpersonal skills.
- Computer skills (Microsoft Word, Excel, SAP and advantage)
If you are interested in applying for this role please call Linda on +353 1 2784671 or email firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com