Quality Specialist I, Compliance

4 weeks ago

Cork, Ireland Endo Full time

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

Job Description

The Quality Specialist I, Quality Operations contributes to various aspects of quality systems, such as Product Complaints, Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events. Assists with various aspects of development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.

Responsible for CMO/CPO Quality Operations and Quality Systems for Change Control, CAPA, routine Deviations and Investigations.

Quality Operations

  • Assesses risk level associated with NCRs, and escalates to management.
  • Assists with various aspects of development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.
  • Communicates due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time.
  • Contributes to various aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.
  • Monitors stability program ad ensures gathering of data out of specification investigations and summary reports are timely and compliant.

60%

Quality Documentation/Report Review

  • Prepares controlled documents (e.g. SOP’s, APRs) required for compliance.
  • Completes assigned duties and responsibilities (filing, etc.).

20%

Continuous Improvement

  • Supports self-audit checks and evaluates CAPA effectiveness checks.

10%

Inspection Readiness

  • Assists in the preparation of materials for inspection readiness and management review.

10%

Qualifications

Education & Experience

  • Bachelor’s degree in a scientific related field with a minimum of 0-2 years’ relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry.
  • Technical and quality background related to the sciences.

Knowledge

  • General understanding of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).
  • Working knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.

Skills & Abilities

  • Good verbal and communication skills required.
  • Attention to detail required.
  • Demonstrated excellent interpersonal skills and flexibility.
  • Ability to handle multiple priorities in a fast paced environment.
  • Good writing skills.
  • Strong organizational skills.
  • Ability to build peer relationships.

Physical Requirements

  • Routine office work (sit/stand).
  • Business travel occasionally as needed..

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

  • Associate Quality Specialist

    4 weeks ago

    Cork, Ireland PSC Biotech Full time

    Associate Quality Specialist (Quality Systems) Industry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Cork State/Province Cork Country Ireland Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in...

  • AML QA Specialist

    4 weeks ago

    Cork, Ireland Amazon Ireland Support Services Limited - A94 Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Chinese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...

  • AML QA Specialist

    1 month ago

    Cork, Ireland Amazon Ireland Support Services Limited - A94 Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Portuguese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...

  • Quality and Compliance Director Food Testing Ireland

    1 month ago

    Cork, Ireland Eurofins Full time

    Job Description HOW CAN YOU HELP US? In a nutshell : Are you interested in leading the Quality and Compliance functions across four Eurofins Food Testing locations in the Republic of Ireland and Northern Ireland? The Director of Quality and Compliance is responsible for leading an integrated management system to provide oversight of Quality,...

  • Associate Specialist

    3 weeks ago

    Cork, Ireland PSC Biotech Ltd Full time

    About PSC Biotech Who we are?  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...

  • Documentation Specialist

    1 month ago

    Cork, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho we are?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...

  • Documentation Specialist

    1 month ago

    Cork, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout PSC BiotechWho we are?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...

  • Client Onboarding Senior Specialist

    4 weeks ago

    Cork, Ireland Alter Domus Full time

    Client Onboarding Senior Specialist Location: Cork, IE ABOUT US  We are Alter Domus. Meaning “The Other House” in Latin, Alter Domus is proud to be home to 85% of the top 30 asset managers in the alternatives industry, and more than 5,000 professionals across 23 countries.  With a deep understanding of what it takes to succeed in...

  • Marketing Specialist, Retention

    1 month ago

    Cork, Ireland McAfee Full time

    Role Overview:As a critical member of the McAfee retention team, the digital marketing specialist will be responsible for driving key business metrics through data-driven experimentation, and optimization. This person will report to the Manager of Retention Marketing and be responsible for identifying, planning, executing, and monitoring the performance of...

  • Payroll Specialist/ Senior Specialist

    4 days ago

    Cork, Ireland Redac LTD TA Barden Full time

    Barden are delighted to be partnering with the Payroll Manager of a very well known Irish Company looking for an experienced Payroll Specialist to join their team. The successful candidate will be responsible for managing payroll for Irish employees and ensuring compliance with local laws and regulations. This is permanent role on a team with a positive,...

  • Senior Manager Quality Control Laboratory

    4 weeks ago

    Cork, Ireland TEAM HORIZON Full time

    Description Team Horizon is seeking a Senior Manager Quality Control Laboratory for our client based in Cork. Embedding operational excellence principles and mindset across all processes and personnel, you will also be responsible for the analysis, review and release of raw materials, bulk products and finished products in compliance with current quality...

  • MSAT Specialist- Thermal

    3 weeks ago

    Cork, Cork, Ireland Cpl Full time

    Kenny-Whelan (a specialist division of the CPL group) are hiring a MSAT specialist -Thermal Validation to work on contract at Janssen Sciences in Ringaskiddy CorkMSAT Specialist – Thermal (12 months) Location: Ringaskiddy, Cork, Ireland Reports to: Manager, Manufacturing Science & Technology Position Summary: We have an exciting opportunity for a MSAT...

  • Quality Assurance Specialist

    3 weeks ago

    Cork, Ireland Westbourne IT Global Services Full time

    Main Duties & Responsibilities · Provides clerical and administrative support related to GxPlearn and GVault. · Responsible for Archiving, filing and maintenance of training related documents. · Maintains documentation manuals to ensure accuracy and current information. · Ensure the correct and timely input of training related documents into the...

  • Quality Assurance Specialist

    3 weeks ago

    Cork, Ireland Westbourne IT Global Services Full time

    Main Duties & Responsibilities ·Provides clerical and administrative support related to GxPlearn and GVault. ·Responsible for Archiving, filing and maintenance of training related documents. ·Maintains documentation manuals to ensure accuracy and current information. ·Ensure the correct and timely input of training related documents into the GxPLearn...

  • Documentation Specialist

    4 weeks ago

    Cork, Ireland PSC Biotech Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Cork State/Province Cork Country Ireland Job Description About PSC Biotech Who we are? 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,...

  • Quality Technician

    3 weeks ago

    Cork, Cork, Ireland Cpl Full time

    Work Your Magic with us Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Environment Health

    4 weeks ago

    County Cork, Ireland Asset Recruitment Full time

    ref. 01181 Environment Health & Safety Specialist Join an exciting opportunity as an Environment, Health, and Safety Specialist. As a crucial member of our client’s site EHS team, you will play a key role in providing support, guidance, and expertise to your assigned area, ensuring strict adherence to environmental and safety requirements. The...

  • Senior Tax Specialist

    4 weeks ago

    Cork, Ireland Johnson Controls Full time

    What will you do The EMEA Tax CoE is responsible for the EMEA Tax compliance and USGAAP / Local Gaap Tax accounting including calculations of income and deferred taxes under local (national) tax rules.  In addition, the CoE supports the regional tax management with data needs in view of projects, compliance, technology and controversy. The team also...

  • EHS Specialist

    4 weeks ago

    Cork, Cork, Ireland Cpl Full time

    EHS Specialist Kenny-Whelan are sourcing an EHS Specialist for a permanent position with benefits, for our client , a Sterile Infant Nutrition manufacturing plant in CorkContact Elaine on or send CV directly to - EHS Specialist Responsibilities Lock Out Tag Out (LOTO)· In consultation with our EHS Manager support the evolution, coordination and...

  • Tax Compliance Manager

    3 weeks ago

    Cork, Ireland BARDEN Full time

    A new opportunity for a tax manager or consultant to join the Corporation Tax Compliance team within a big 4 firm based in Cork. Flexible working arrangements are available including an option for a 4 day week. You will be part of a great team and work on some of the most dynamic and fast growing Irish and international groups, listed and unlisted...