Leading pharmaceutical manufacturer seeks an experienced Quality Assurance Specialist for a 12-month contract. This specific role is required to primarily support the site quality system metric generation and reporting as well as leading and supporting changes and improvements related to the application of the quality system. The role will also provide support for onsite IUC departments as a QA approver for quality system elements such as deviations, documentation updates, change controls.
In this role, the candidate may be responsible for performing a wide variety of activities to ensure compliance with applicable regulatory requirements:
- Provide support for onsite departments in assessing and approving quality system records such as deviations, change controls and document updates.
- Represent QA on global quality system related initiatives such as global risk management and other improvement projects impacting application of quality system.
- Support the management and updates to the IUC quality risk register.
- Participate in and lead improvement initiatives for the quality system at IUC.
- Participate in developing standard operating procedures (SOPs) to ensure quality objectives are met.
- Participate in the development and delivery of quality system related training programs.
- As required lead investigations and corrective and preventive actions (CAPA) for QA relevant investigations.
- Participate in and lead internal audits and walkthroughs at IUC and provide assistance in compliance audits as required.
- Maintain routine programs and processes to ensure high-quality products and compliance with current good manufacturing practices (GMPs).
Knowledge and Skills Required:
- Demonstrates proficiency in current good manufacturing practices (GMPs)
- Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
- Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
- Demonstrates strong verbal, technical writing, presentation and interpersonal skills.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
- Demonstrates proficiency in Microsoft Office applications.
Typical Education and Experience
- 6+ years of relevant experience in a GMP environment related field and a BS.
- 4 + years of relevant experience and a MS.
- Prior experience in the pharmaceutical industry is preferred.
Full-time, 12 Month Contract
For a confidential discussion on this or any other current opportunity please contact Nicola Murphy on 021 233 9200 / email@example.com
Please note that your application for this vacancy will be forwarded to all the consultants in The Logiskills Group as you may be suitable for other roles that we are unable to advertise.
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