Operations Quality Systems Specialist | Mayo
- Leading Pharma Company in the West of Ireland
- Excellent career progression opportunities along with a generous package.
Oradeo Recruitment is presently seeking interest for an experienced Operations Quality Systems Specialist to join our clients. In this role you will be responsible for the processing of all Analytical Services Department Quality Documents, i.e. Deviations, LIRs, Facility replies, audit responses, change controls, etc.
This position would come with an excellent remuneration package and a clear path for career growth.
Operations Quality Systems Specialist Responsibilities:
- Responsible for the processing of all Analytical Services Department Quality Documents, i.e. Deviations, LIRs, Facility replies, audit responses, change controls, etc.
- Tracking and applying corrective/preventive actions and checking effectiveness of same.
- Assessing the impact of changes to facilities/systems/equipment and processing of change control documents.
- Liaise with the Quality Assurance Department to process quality documents.
- Generate new and update current standard operating procedures if required by CAPA
- Assist with the implementation of systems to improve Quality and raise Quality awareness among staff in the Analytical Services Department.
- Review of data.
- Dealing with internal and external customers as required.
- Involvement with regulatory and client audits as required.
The successful candidate must have:
- Scientific/Quality Systems qualification.
- 2--4 years’ experience of working in a Medical Device/Pharmaceutical/CRO industry i.e. GMP/Quality experience.
- GMP background essential. Comprehensive understanding of GMP compliance and how it relates to the quality system.
- IT skills – MS Word, Excel, Powerpoint etc.
- Meticulous attention to detail and high level of accuracy.
- Excellent problem-solving skills.
- Excellent interpersonal & communication skills, both written and verbal.
- Positive attitude
- Excellent report writing skills.
- Ability to work on own initiative as well as part of a team.
- Flexibility - Ability to work overtime as required.
- Technical knowledge of Analytical testing is essential, with particular focus on HPLC/UPLC systems and knowledge of Empower 3