Description
Senior Quality Assurance Specialist - Dublin - 12 Month Contract - €500 per dayOptimus Life Sciences are working with a Biopharmaceutical Client based in Dublin to hire a highly experienced QA Specialist to work on-site. This role sits within Pharmaceutical Manufacturing, focusing specifically on the establishment and improvement of the Quality Management System.
The location for this role will be a production site manufacturing drug products. As part of the role you will be expected to assist in development and process improvement as well as working with the QMS.
The company are looking for a start early May, the interview process will incorporate a face to face meeting so please be aware that travelling will be involved when applying to the job. If you are interested in finding out more, please send a CV to Robert Marrett () or Dean Fuller () to organise a chat in more detail.
Tasks
- Implement, maintain and improve a new Quality Management System for the facility.
- Train staff in GMP, assuring that guidelines are met and that there is a quality led culture within the company.
- Oversee investigations, ensuring these are conducted properly and all findings are reported and resolved in a timely manner.
- To conduct supplier audits, Internal audits and co-ordinate regulatory audits.
- Perform QA inspection of production equipment and facilities.
- Review and evaluate technical reports from the development function.
- To review analytical, cleaning and equipment validation documents.
Requirements
- Minimum 8 years' experience working in a similar position.
- 5 years' experience working on a GMP Manufacturing site within the (Bio)pharmaceutical Industry.
- A decent understanding of cGMP Systems.
- Sterile manufacturing and/or biotech experience is preferable.
- Good computer skills, including proficiency with business and technical software (Word, Access, Excel, PowerPoint, SAP, TrackWise).
- Ability to work on-site in Dublin.