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Urgent! QA Specialist - Validation and NPI - Local Job Opening in Carlow
Quality Assurance Specialist – Validation and NPI
An amazing opportunity has arisen for a Quality Assurance Specialist to join the quality team within a leading Biopharmaceutical Multinational.
As a member of the Tech Transfer/Validation Team you will play a vital role in supporting the introduction of new products and Quality oversite of executed validation completed at this Carlow based facility.
Responsibilities:
* Provide quality oversight and direction for the introduction of new products.
* Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
* Participate as a functional expert in the cross-functional team responsible for introducing products
* Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
* Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
* Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation.
* Support deviation close out in a timely manner.
* Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
Actively participate in Plant/Quality committees and collaborate with others
Qualifications and Experience:
* A Bachelor's degree or higher in a related Science discipline is preferred.
* A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Experience in reviewing and approving documents associated with Equipment Validation, Cleaning validation, Sterilization such as Autoclaves and other equipment like CTU's, Isolators etc.
* Quality oversite of equipment Qualification and knowing how to review and approve the following documents IQ, OQ, PQ, IOC, IOQ's etc.
* Experience of systems Kneat, IPI, Veeva Vault would be an advantage.
* Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
* Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
* Strong report, standards, and policy writing skills.
* Experience with equipment and process validation.
* Familiarity with sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications.
* Experience or familiarity with Lean Six Sigma methodology is desired.
.For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)
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Unlock Your QA Specialist Potential: Insight & Career Growth Guide
Real-time QA Specialist Jobs Trends in Carlow, Ireland (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for QA Specialist in Carlow, Ireland using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 1587 jobs in Ireland and 10 jobs in Carlow. This comprehensive analysis highlights market share and opportunities for professionals in QA Specialist roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Headcount Solutions Limited is currently hiring and seeking a QA Specialist Validation and NPI to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: QA Specialist Validation and NPI Jobs Carlow.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Headcount Solutions Limited adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a QA Specialist Validation and NPI Jobs Ireland varies, but the pay scale is rated "Standard" in Carlow. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for QA Specialist Validation and NPI typically include Medical/pharmaceutical/scientific and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your QA Specialist Validation and NPI interview at Headcount Solutions Limited, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Headcount Solutions Limited's products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
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