Crest Solutions is seeking a talented Quality Assurance Specialist to join our team in Cork on a fixed term contract.
Job Summary: The candidate will be required to work within the Quality Assurance Department to help maintain quality standards throughout the company. This experienced position requires sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment within well-defined and established procedures and practices to determine appropriate action, to identify problems and to generate alternatives and recommendations within defined processes. The candidate will lead and coordinate reviews and investigations as well as general quality system support activities. Knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.
- Provide quality assurance services to the required group (manufacturing, engineering, facilities, packaging, supply chain, IT, validation and label operations).
- Quality Review of Batch Records.
- QA representative in the investigation into non-conformances, participate in root cause analysis and agree corrective and preventive action (CAPA) recommendations related to manufactured products.
- Preparation and revision of cGMP documentation, Annual Product Reviews, Protocols, Standard Operating Procedures, etc, within the QA Department as required.
- Support the site Quality Management systems including; the Deviation and CAPA Management systems, Change Control system, Complaints System etc.
- Works with contract manufacturers to address standard documentation and compliance issues.
- Supports the maintenance of monthly document control metrics.
- Participate fully in any department /cross functional training initiatives.
- Supports internal and regulatory audits as required.
- Participate in and facilitate continuous improvement projects as required.
- Member of the Self-Inspection Audit Team.
- Provides additional support and assistance on tasks and projects as directed by management.
- Normally receives very little instruction on routine work, general instructions on new assignments.
- Deliver on agreed KPIs and metrics.
- Other duties as requested.
- A relevant third level qualification in an QA discipline or relevant experience.
- Relevant industrial experience in a QA role ideally in the pharmaceutical sector.
- Technical knowledge of Document Control fundamentals, Quality Systems and GMP requirements.
- Understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, EMEA and ICH etc.
- Working knowledge of Electronic Document Management Systems (EDMS).
- Keeps abreast of the requirements for compliance in own work area.
- Demonstrates sound judgement within well-defined and established procedures and practices to determine appropriate action.
- Proven experience of investigations and resolving problems.
- Strong attention to detail.
- Proficiency in Microsoft Office applications and Oracle environment.
- Excellent written and spoken communication skills with a proven ability to communicate with cross-functional peers and present process/product performance to multiple audiences.
- A can-do attitude towards customer delivery and performance.
Why Join Crest Solutions?
In Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. As part of the Crest Solutions team, you will be exposed to, and have the opportunity to work with, the latest cutting-edge technologies. The experience you gain in Crest Solutions will be multi-faceted.
This role also includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:
- Competitive salary
- Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme
- A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment
- A structured approach to professional development opportunities with an educational assistance programme
Crest Solutions is an equal opportunity employer.