Senior Quality Assurance Associate

2 months ago

Dublin, 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 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.



The Senior associate in quality assurance (QA) will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.  The Sr. associate in quality assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components. 

The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr. Associates may be asked to carry out additional work functions to support site continuous improvement activities.



Requirements

Key Responsibilities:

•          Testing of primary and secondary components for use in the manufacture of aseptic products.

•          Sampling of Excipients and Drug Substance under Grade C conditions.

•          Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities

•          Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable

•          Provide training and advice to staff in relation to testing of components and packaging.

•          Actively participate in audits and their preparation.

•          Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation

•          Write, review and approve Standard Operating Procedures in accordance with client Policies.

•          Perform all activities in compliance with client safety standards and SOPs

•          Support continuous improvement and Operational Excellence initiatives

•          Any other tasks/projects assigned as per manager’s request.

 

Basic Qualifications & Experience:

•          Must Pass Eye-Tests required for Visual Inspection

•          University degree. Engineering or Science related discipline preferred.

•          Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

 

Preferred Qualifications & Experience:

•          Excellent written and verbal communication skills

•          Experience working with dynamic cross-functional teams and proven abilities in decision making

•          Strong organizational skills, including ability to follow assignments through to completion

•          Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations

•          Experience working in aseptic operations, protein formulation, vial and syringe filling.



#LI-BR1

  • Senior Quality Assurance Associate

    2 months ago

    Dublin, Ireland TEAM HORIZON Remote Work Freelance Full time

    Description Team Horizon is seeking a Senior Quality Assurance Associate for our Client, who are a leading biotechnology company based in Dublin. Why you should apply: This is an excellent opportunity to join a forward thinking company and work in a state of the art facility. What you will be doing: Testing of primary and secondary...

  • Senior Director of Quality Assurance

    2 weeks ago

    Dublin, Ireland UnitedHealth Group Full time

    Senior Director of Quality Assurance - Dublin or Letterkenny / HybridAs a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.With a strong ecosystem of investment and...

  • Senior Director of Quality Assurance

    2 weeks ago

    Dublin, Dublin City, Ireland UnitedHealth Group Full time

    Senior Director of Quality Assurance - Dublin or Letterkenny / HybridAs a Fortune Global top 10 business, we're one of the world's leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals.With a strong ecosystem of investment and...

  • Senior Director of Quality Assurance

    2 weeks ago

    Dublin, Ireland UnitedHealth Group Full time

    Senior Director of Quality Assurance - Dublin or Letterkenny / Hybrid As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals. With a strong ecosystem of...

  • Head of Quality Assurance

    2 months ago

    Dublin, Dublin City, Ireland ICD Business School Full time

    Join our TeamJob Vacancy: Head of Quality Assurance – ICD Business School, Dublin Institution DescriptionEstablished in 2001, ICD Business School is a higher education institution in Dublin City, accredited by QQI. Our programmes at NFQ levels 8 & 9 offer up to 9 ACCA exemptions. As an institution specialising in accounting and finance, in May 2024, ICD...

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland SEI1GLOBAL Full time

    SEI Investments is a leading global provider of asset management and investment technology solutions. The company's innovative solutions help corporations, financial institutions, financial advisors, and affluent families create and manage wealth. SEI is a people focused organization which encourages and recognizes employee development as being a critical...

  • Senior Quality Assurance Specialist, Device Development Assurance

    2 months ago

    Dublin, Ireland Viatris Full time

    McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...

  • Quality Assurance Advisor

    2 months ago

    Dublin, Ireland GMC Utilities Group Full time

    Are you looking to become part of a collaborative team whilst maximising your potential to grow and develop within your career? Apply today. The Role.GMC are currently looking for an experienced Quality Assurance Advisor to join our team. The successful QAQC Advisor will be supporting the delivery of projects across all aspects of the business from a...

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Ireland SEI1GLOBAL Full time

    SEI Investments is a leading global provider of asset management and investment technology solutions.  The company’s innovative solutions help corporations, financial institutions, financial advisors, and affluent families create and manage wealth. SEI is a people focused organization which encourages and recognizes employee development as being a...

  • Quality Assurance Manager

    6 days ago

    Dublin, Ireland Clinigen Full time

    Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.We are currently 1,100 people headquartered in the UK with global...

  • Quality Assurance Manager

    2 days ago

    Dublin, Ireland Clinigen Full time

    Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.We are currently 1,100 people headquartered in the UK with global...

  • Director, Quality Assurance

    2 weeks ago

    Dublin, Ireland UnitedHealth Group Full time

    Director, Quality Assurance – Dublin or Letterkenny / Hybrid As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.With a strong ecosystem of investment and...

  • QA Senior Associate

    3 weeks ago

    Dublin, 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...

  • Audit and Assurance Director

    1 month ago

    Dublin, Ireland RSM Ireland Business Advisory Limited Full time

    About RSM Ireland RSM Ireland is one of the country's fastest growing advisory firms, specialising in the provision of consulting, audit, and tax services to leading domestic and international mid-market clients. We are a key member of the RSM International network and work closely with over 64,000 colleagues in 820 offices, spanning 120 countries. RSM...

  • Quality Assurance/Quality Controller

    1 month ago

    Dublin, Ireland Crystal Air Full time

    As a result of rapid expansion of the business both in Ireland and Europe we are looking to add to our contracts team the role of Quality Assurance/Quality Controller. The position will be based in Dublin Ireland. To find out more about us Duties & Responsibilities of the role: You will be involved in the planning, coordination, and execution of quality...

  • Food Quality Assurance Coordinator

    4 weeks ago

    Dublin, Ireland Wallace Myers International Full time

    My client seeks a Food Quality Assurance Coordinator to join their Quality Assurance team. The Quality Assurance Coordinator will be responsible for coordinating and participating in all sensory taste panels for both food and near food products, ensuring all new products comply with the nutrition policy, participating in developing and reformulating...

  • Head of Finance Governance and Assurance

    2 months ago

    Dublin, Dublin City, Ireland Cpl Full time

    My client a leader in the Real Estate Sector is hiring a Head of Finance Governance and Assurance to join their team.My client is seeking a highly skilled and experienced finance professional to take on the role of Head of Finance Governance and Assurance. This position involves providing independent oversight of our fee and non-fee earning departments...

  • Quality Assurance Technician

    1 month ago

    Dublin, Ireland Quorum Search Partners Full time

    We have an exciting opportunity for a Quality Assurance Technician to join a leading Food Company in North Dublin. Reporting to the Quality Manager the successful candidate will work within the Quality Team to ensure that day to day production operations are conducted in a quality focused way. Negotiable salary depending on experience approx €30k - €35k....

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Abbott Laboratories Full time

    Quality Assurance Specialist page is loaded Quality Assurance Specialist Apply locations Ireland - Cootehill time type Full time posted on Posted 15 Days Ago job requisition id JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans...

  • Quality Assurance Specialist, Device Development Assurance

    2 months ago

    Dublin, Ireland Viatris Full time

    McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...