Urgent! QA Validation Position in Louth Village - Claran Consultants Ltd
This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs) and shipping.
An important aspect of this role is provision of QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the Dundalk Facility start-up project and supporting the transition from project phase through to sustaining phase with respect to validation activities JOB RESPONSIBILITY Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria.
Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements.
Review SOPs relating to qualification/validation activities.
Provision of support in Regulatory inspections and Client audits.
Provision of QA Validations expertise to maintain validation status of the facility.
Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables.
Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training.
Other quality activities as needed and assigned.
Education background/ Experience B.Sc. or B.
Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).
Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in an FDA/ EU regulated environment.
Thorough understanding of the validation requirements associated with a cGMP manufacturing facility Strong technical aptitude is required.
Special knowledge Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.
Knowledge of trouble shooting and problem-solving skills.
Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc.
Skills Independent and self-motivated.
Able to multi-task in fast-paced, dynamic working environment.
Strong planning, organisational, and time management skills.
Critical thinking skills.
Able to operate across functional boundaries, both internal and external.
Skills: Validation Commissioning CQV GAMP GXP
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Unlock Your QA Validation Potential: Insight & Career Growth Guide
Real-time QA Validation Jobs Trends in Louth Village, 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 Validation in Louth Village, 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 287 jobs in Ireland and 2 jobs in Louth Village. This comprehensive analysis highlights market share and opportunities for professionals in QA Validation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Claran Consultants Ltd is currently hiring and seeking a QA Validation 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 Validation Jobs Louth Village.
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 Claran Consultants Ltd adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a QA Validation Jobs Ireland varies, but the pay scale is rated "Standard" in Louth Village. 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 Validation typically include Engineers 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.
To improve your chances of getting hired for QA Validation, consider enhancing your skills. Check your CV/Résumé Score with our free Resume Scoring Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.
Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your QA Validation interview at Claran Consultants Ltd, 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 Claran Consultants Ltd'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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