QA Technical Specialist
3 weeks ago
We are currently looking for a QA Technical Specialist to join a leading pharmaceutical company based in Ireland. As the QA Technical Specialist you will be responsible for managing and implementing a brand new MES System. you will be responsible for thedesigning, installation and evaluation using your own leadership and expertise to qualify a MES system fit for use.
**KEY DUTIES AND RESPONSIBILITIES**:
Your duties as the QA Technical Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for the development and implementation of a new MES system. this would include the review of MES documentation that will support MES change control.
2. you will have to act as a lead providing quality support managing the MES project ensuring the project is delivered in a timely manner.
3. As QA technical specialist you will be responsible for the development and implementation of the master batch records and will need relevant experience using electronic batch records.
4. in addition to the above you would need to have experience in general QA activities such as Deviations, CAPA's and change controls.
**ROLE REQUIREMENTS**:
1. Relevant degree in Pharmaceutical background.
2. Proven industry experience in Quality Assurance.
3. A working knowledge and practical experience with MES systems and batch records.
Key Words: MES | manufacturing execution system | EBR | CAPA's | change controls | Deviations | GMP | GLP | SOP'S | QA | Pharmaceutical | GxP | Validation | Documentation | MBR | Electronic Batch Record | Master Batch Record | UAT testing
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