Associate Specialist, Quality Assurance-Shift
3 days ago
- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 1-3 years
- City: Carlow
- State/Province: Carlow
- Country: Ireland
About PSC Biotech
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.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech. We provide unparalleled career development through in-house training and mentorship to facilitate career progression. We believe in creating high-performing teams that can exceed our clients' expectations regarding quality, staying under budget, and ensuring timelines for our deliverables are met.
Overview:
- Responsible for ensuring that the process for the manufacture of drug products at our site is in compliance with cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety, and reliable supply to our customers.
- For applicants, it is important to note that this role is onsite; 2 cycle. The shift pattern will be discussed in the interview, as patterns of shift will differ at project stages.
Principal Accountabilities:
Documentation:
- Review and approval of all manufacturing batch documentation including electronic batch records, real-time reports, and master data using the site systems.
- Review and approval of SOPs, cleaning verification/validation data, and other documents as necessary for the IPT department.
- Drive effective writing/revising/rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with the same.
- Support the development and implementation of improved quality reporting measures.
- Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to the batch manufacturing process.
Quality Oversight:
- Work collaboratively to drive a safe and compliant culture.
- Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.
- Provide effective real-time on-the-floor support for day-to-day manufacturing operations, for example, area clearances, batch record reviews, aseptic operations.
- Provide quality input into the decision-making process on the shop floor ensuring that product quality is maintained.
- Provide training in all aspects of Quality Management Systems and GMP.
- Ensure all work is carried out in line with SOPs, training, or other quality systems such as change controls where applicable.
- Facilitate compliance direction for the site by assisting in adherence to divisional policies and guidelines as well as regulatory requirements.
- Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
- Actively participate in Plant/Quality committees and work with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant-wide GMP initiatives.
- Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.
- Partner with colleagues cross-functionally to provide support and advice on a day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries, etc.; thereby ensuring IPT is audit/inspection ready. Conduct area inspections for IPT as appropriate.
Initiate and maintain Quality related metrics, ensuring effective communication and follow-up of same. Such ongoing monitoring/metrics gathering may include:
- Monitoring of quality systems
- The self-inspection program
- Verification of the effective implementation of key GMP programs
- Effectiveness of Preventative Actions
- Leadership activities including selection, development, coaching, and day-to-day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills to complete their jobs whilst stimulating personal growth and development in line with the role.
- Develop and maintain training programs.
- Required to comply with Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture.
- May be required to perform other duties as assigned.
Skills and Knowledge:
- Third Level Degree qualified in a Science/Technical or related discipline.
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
- GMP Audit experience in the pharmaceutical industry.
- Problem-solving/critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues and trends.
- Communication, decision making, people influencing, and project management skills will be important.
- Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
- Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
-
Quality Assurance Associate
2 weeks ago
Dublin, Dublin City, Ireland MatchSTEM Full timeAssociate Specialist, Quality Assurance11 month contract position on 2 cycle shift. 20% shift premium.Responsible for ensuring that the process for the manufacture of drug product at the Carlow site is in compliance with cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate...
-
Quality Assurance Specialist
3 days ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeQuality Assurance Specialist - South-East, Ireland - 11 Months ContractDo you want to be involved with exciting pharmaceutical projects?When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are...
-
Quality Assurance
2 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dublin State/Province Dublin Country Ireland 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,...
-
Quality Assurance
2 days ago
Dublin, Dublin City, Ireland PSC Biotech Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dublin State/Province Dublin Country Ireland 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,...
-
Associate Specialist, Quality Assurance
3 days ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Carlow State/Province Carlow Country Ireland Job Description About PSC Biotech 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...
-
Compliance Specialist
2 days ago
Dublin, Dublin City, Ireland Saol Assurance Full timeSaol Assurance Dublin, County Dublin, IrelandWe're Saol Assurance. We're a Life Assurer offering protection, pensions and investment products. We are a progressive and purposeful business that aims to have a positive impact on society. We are reshaping the Irish financial industry and our focus is on building a life insurance company that provides relevant,...
-
Associate Specialist, Quality Assurance
3 days ago
Dublin, Dublin City, Ireland PSC Biotech Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Carlow State/Province Carlow Country Ireland Job Description About PSC Biotech 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...
-
Quality Assurance Academic Specialist
2 weeks ago
Dublin, Dublin City, Ireland Dublin Business School Full timePosition: Quality Assurance Academic SpecialistLocation: Dublin Business School, 13/14 Aungier Street, Dublin 2Working Hours: Monday-Friday, 39 Hours per Week, 9 am - 5.30 pmPrimary objective:The Quality Assurance Academic Specialist plays a vital role in supporting the Academic Operations team in all aspects of student record quality. They act as a liaison...
-
Quality Assurance Specialist
2 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeQuality Assurance SpecialistExcellent opportunity for an experienced Quality Assurance specialist to work within our expanding supply chain team to develop our quality assurance activity. This new role will advance our QA program, working closely with our internal supply chain, compliance and product functions as well as external partners to develop our...
-
Quality Assurance Specialist
2 days ago
Dublin, Dublin City, Ireland CPL Full timeQuality Assurance SpecialistExcellent opportunity for an experienced Quality Assurance specialist to work within our expanding supply chain team to develop our quality assurance activity. This new role will advance our QA program, working closely with our internal supply chain, compliance and product functions as well as external partners to develop our...
-
Technical Quality Assurance Specialist
3 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeTechnical Quality Assurance SpecialistThis is an exciting opportunity with a leading multinational pharmaceutical organization based in Dublin.Duties:Provide quality input for processes and procedures associated with technology transfer, NPI, and product lifecycle changes.Act as a key Quality team member during technology transfer activities, ensuring...
-
Senior Quality Assurance Specialist
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeSenior Quality Assurance SpecialistRK385418 MonthsDublinWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties:1. Provide overall quality direction for...
-
Technical Quality Assurance Specialist
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeTechnical Quality Assurance SpecialistLocation: Hybrid, DublinReference: RK3852Duration: 12 MonthsWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they...
-
Senior Quality Assurance Associate
1 week ago
Dublin, Dublin City, Ireland TEAM HORIZON Remote Work Freelance Full timeTeam 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 components for use in the...
-
Quality Assurance Specialist
2 weeks ago
Dublin, Dublin City, Ireland Shorla Oncology Full timeShorla Oncology develops innovative solutions into effective oncology treatments to improve patients' lives. The patients' needs are at the heart of our innovation, ensuring we deliver affordable, accessible medicines and provide a significant clinical impact.Shorla Oncology has core values of compassion, commitment, innovation, tenacity, and collaboration....
-
Quality Assurance Technician
2 weeks ago
Dublin, Dublin City, Ireland Hunter Savage Full timeJob Opportunity: Quality Assurance Technician – Food ProductionLocation: Rathmooney, DublinType: Full-timeAbout the Role:Our client are seeking a dedicated and detail-oriented Quality Assurance Specialist to join their team within a leading food manufacturing company. Reporting to the Quality Manager, you will play a crucial role in ensuring that daily...
-
Quality Assurance Technician
2 weeks ago
Dublin, Dublin City, Ireland Hunter Savage Full timeJob Opportunity: Quality Assurance Technician – Food Production Location: Rathmooney, DublinType: Full-timeAbout the Role:Our client are seeking a dedicated and detail-oriented Quality Assurance Specialist to join their team within a leading food manufacturing company. Reporting to the Quality Manager, you will play a crucial role in ensuring that daily...
-
Quality Assurance Specialist
2 days ago
Dublin, Dublin City, Ireland Matthew Clark Bibendum Full timeBulmers is part of C&C Group plc, a premium drinks company which owns, manufactures, markets and distributes a unique portfolio of beer and cider brands in its home markets and across the globe. You probably know us best from brands like Bulmers, Magners and Tennent's.About the roleOur site in Clonmel is the home of Irish cider. And our Quality team are...
-
Quality Assurance Specialist
3 days ago
Dublin, Dublin City, Ireland C&C Group Plc Full timeBulmers is part of C&C Group plc, a premium drinks company which owns, manufactures, markets and distributes a unique portfolio of beer and cider brands in its home markets and across the globe. You probably know us best from brands like Bulmers, Magners and Tennent's.About the roleOur site in Clonmel is the home of Irish cider. And our Quality team are...
-
Quality Assurance Specialist
2 days ago
Dublin, Dublin City, Ireland Amarin Corporation Full timeQuality Assurance Specialist page is loadedQuality Assurance SpecialistApply locations Dublin, Ireland time type Full time posted on Posted 7 Days Ago time left to apply End Date: March 12, 2025 (5 days left to apply) job requisition id JR641At Amarin, you'll make a difference.Our vision is to one day reach the moment when heart disease is no longer the #1...