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QA Validation Job Opening In Louth Village – Now Hiring Claran Consultants Ltd


Job description

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

Required Skill Profession

Engineers


  • Job Details

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Unlock Your QA Validation Potential: Insight & Career Growth Guide


Real-time QA Validation Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for QA Validation in Louth Village, Ireland, highlighting market share and opportunities for professionals in QA Validation roles.

280 Jobs in Ireland
280
2 Jobs in Louth Village
2
Download Qa Validation Jobs Trends in Louth Village and Ireland

Are You Looking for QA Validation Job?

Great news! 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: .

The Work Culture

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:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying Ireland laws and regulations

What Is the Average Salary Range for QA Validation Positions?

The average salary range for a 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.

What Are the Key Qualifications for QA Validation?

Key qualifications for QA Validation typically include Engineers and a list of qualifications and expertise as mentioned in the job specification. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

How Can I Improve My Chances of Getting Hired for QA Validation?

To improve your chances of getting hired for QA Validation, consider enhancing your skills. Check your CV/Résumé Score with our free 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.

Interview Tips for QA Validation Job Success

Claran Consultants Ltd interview tips for QA Validation

Here are some tips to help you prepare for and ace your QA Validation job interview:

Before the Interview:

Research: Learn about the Claran Consultants Ltd's mission, values, products, and the specific job requirements and get further information about

Other Openings

Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

Dress Professionally: Choose attire appropriate for the company culture.

Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

During the Interview:

Be Punctual: Arrive on time to demonstrate professionalism and respect.

Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.

Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.

Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.

Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.

Follow Up: Send a thank-you email to the interviewer within 24 hours.

Additional Tips:

Be Yourself: Let your personality shine through while maintaining professionalism.

Be Honest: Don't exaggerate your skills or experience.

Be Positive: Focus on your strengths and accomplishments.

Body Language: Maintain good posture, avoid fidgeting, and make eye contact.

Turn Off Phone: Avoid distractions during the interview.

Final Thought:

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!

How to Set Up Job Alerts for QA Validation Positions

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