Crest Solutions is seeking a talented Quality Assurance Specialist to join our team in Cork.
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 packaging group to ensure business, quality and compliance goals are met
- Batch Record Review to ensure compliance with GMP requirements
- 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 including review and approval of deviations and customer complaints.
- QA Review and approval of cGMP documentation, Protocols, Standard Operating Procedures, forms etc,
- Support the site Quality Management systems including; the Deviation and CAPA Management systems, Complaints System etc.
- Supports and assists in the preparation for regulatory and internal GMP inspections of the site.
- 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.
- Participate in and facilitate continuous improvement projects as required.
- 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 a QA discipline or relevant experience.
- Minimum of 1 years experience in similar role
- 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
- 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.
- Ability to work as part of a team is critical
- Adaptable and flexible
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
Apply via our Careers Portal at www.crestsolutions.ie/careers
Not ready to apply or have questions?
Call HR on 021 452 4767
Crest Solutions is an equal opportunity employer.