Senior QA Associate - Athlone, Ireland
|Job Title:||Senior QA Associate - Athlone, Ireland|
|Location:||Republic of Ireland, Republic of Ireland|
|Contact Name:||Nathan Wilson|
|Job Published:||September 07, 2017 10:17|
- Full understanding of GMP requirements in routine operations.
- Awareness and application of Pharmaceutical Regulations in own area.
- Work proactively as part of a team and provide constructive input into resolution of problems impacting on Quality, project, or material.
- Co-ordinate the review and closure of technical customer complaints.
- Participate in compiling and maintaining departmental KPIs, monitor and evaluate trends.
- Support the self-inspection program.
- Support Change control and periodic reviews by authoring and reviewing changes.
- Prepare Reports i.e. technical and trend reports.
- Support regulatory and customer audits.
- Support customer expectations in relation to product shipments and issue resolution.
- Work with other departments to ensure quality systems are maintained.
- Attend meetings related to key responsibilities.
- Ensure adherence with best health and safety practices.
- A third level qualification in a science, analytical or pharmaceutical discipline is required.
- 5 years' experience in the pharmaceutical industry. Where appropriate a combination of experience and education will be considered.
- Knowledge and experience of SAP, Trackwise, Veeva, Next Docs or similar quality systems would be beneficial.
- In-depth knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory requirements for pharmaceutical products.
- Competency in the use of computerised systems.
- Good organisational, communication and interpersonal skills.
- Good report writing skills and attention to detail and accuracy.
- Proven track record in your current role is essential.
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