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Senior QA Specialist Job Opening In Tipperary – Now Hiring PSC Biotech Ltd


Job description

Job Description

About PSC Biotech

 

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.

We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

 

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry.

We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

 

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression.

We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA.

You will take ownership of maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.
Initially required onsite for training once training has been completed 1 day a week from home

 



Requirements

Key Responsibilities:

  • Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
  • Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
  • Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
  • Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
  • Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
  • Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
  • Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.

 

 Qualifications & Education:

  • Degree in Science, Quality, or a related Technical field.
  • 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
  • Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
  • Logical thinker with the ability to remain proactive and composed under pressure.
  • Proven ability to work effectively both independently and collaboratively within a team.
  • Exceptional attention to detail and precision in preparing and reviewing GMP documentation.
  • Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms


 




Requirements
Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.

Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.

Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.

Required Skill Profession

Business Operations Specialists


  • Job Details

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Unlock Your Senior QA Potential: Insight & Career Growth Guide


Real-time Senior QA 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 Senior QA in Tipperary, Ireland, highlighting market share and opportunities for professionals in Senior QA roles.

6570 Jobs in Ireland
6570
25 Jobs in Tipperary
25
Download Senior Qa Jobs Trends in Tipperary and Ireland

Are You Looking for Senior QA Specialist Job?

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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 PSC Biotech 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 Senior QA Specialist Positions?

The average salary range for a varies, but the pay scale is rated "Standard" in Tipperary. 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 Senior QA Specialist?

Key qualifications for Senior QA Specialist typically include Business Operations Specialists 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.

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Interview Tips for Senior QA Specialist Job Success

PSC Biotech Ltd interview tips for Senior QA Specialist

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

Before the Interview:

Research: Learn about the PSC Biotech 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 Senior QA Specialist interview at PSC Biotech 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 PSC Biotech 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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