Quality Specialist
2 months ago
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:
- The Quality Specialist ensures adherence to Good Manufacturing and Documentation Practices, client’s Quality Manual and local procedures.
- The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.
Requirements
Primary Responsibilities:
- Provide direct Quality support to production and support areas.
- Provides presence on the shop floor to support compliance and data integrity.
- Review and approve GMP documentation/data for accuracy and completeness.
- Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
- QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents.
- Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs.
- Provides support to internal audits and regulatory inspections.
- Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
General competencies:
- MES experience desirable
- Desire to continuously learn, improve and develop.
- Leadership skills coupled with good oral and written communication skills.
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
Technical:
- Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.
- Technical writing skills.
- Lean Six-sigma and problem solving tools.
Minimum Education/Experience:
- Bachelor degree, in a scientific or engineering field.
- 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.
#LI-AM1
-
Quality Specialist
4 weeks ago
Dublin, Ireland ESB Full timePosition Description Are you looking for a new challenge? A Brighter, zero carbon future awaits! Join the Capability Assurance (CAM) team in Transmission and Distribution Engineering (TDE) in ESB Engineering and Major Projects. We are responsible for the Quality Management processes, safety coordination, and developing the Engineering capability within the...
-
Quality Specialist
2 months ago
Dublin, Ireland PSC Biotech Ltd Full timeJob DescriptionAbout PSC BiotechWho 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...
-
Quality Systems Specialist
6 months ago
Dublin, Ireland TEAM HORIZON Remote Work Freelance Full timeDescription Team Horizon is seeking a Quality Systems Specialist for our client, a leading Biotechnology company in Dublin. This is a 12-month initial contract. Why you should apply: Exciting opportunity to provide QMS support for combination products for the product lifecycle and the associated Quality System and engage with all stakeholders...
-
Management Sys Specialist/ Quality Analyst
3 weeks ago
Dublin, Ireland Brightwater Full timeManagement Systems Specialist/ Quality Analyst 6 Months Temporary Contract About the Company My client is a well-known public sector organisation, currently seeking multiple candidates forManagement Systems Specialist / Quality Analyst roles. About the Position This will initially be a 6 Month temporary contract with high likelihood of extension or...
-
Claims Quality Review Specialist
4 months ago
Dublin, Ireland Berkshire Hathaway Specialty Insurance Full timeJob Opportunity: Berkshire Hathaway Specialty Insurance (BHSI) is seeking a Claims Quality Review Specialist to join the Global Claims Quality Assurance. This role can be based in any one of our main European locations, including London, Cologne, Paris, Madrid or Dublin. This position entails regular communication and collaboration with multiple...
-
Senior Quality Specialist
4 months ago
Dublin, Ireland Endo Operations Limited Full timeDescription The Senior Quality Specialist, Quality Operations leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. Provides quality guidance on product transfers and validations and will ensure that all activities related...
-
Quality Experience Specialist
3 months ago
Dublin, Ireland SSE Enterprise Full timeWhat is the Role The Quality Experience Specialist is an important role within the wider Customer Experience function, supporting our internal Operations teams with the facilitation and delivery of customer first outcomes. You will monitor, measure and share key insights relating to customer transactional touchpoints, in turn playing a critical role in...
-
Senior Quality Specialist
6 months ago
Dublin, Ireland West Pharmaceutical Services Full timeAt West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and...
-
QA Specialist, External Quality
6 months ago
Dublin, Ireland TEAM HORIZON Remote Work Freelance Full timeDescription Team Horizon is seeking a QA Specialist for External Quality for our client, who are a leading biopharmaceutical company based in Dublin. In this role you will support ongoing quality assurance responsibilities in support of Contract Manufacturing oversight and quality systems. Why you should apply: This is an excellent opportunity to...
-
Dublin, Ireland Viatris Full timeMcDermott 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...
-
Civil Foreman
1 month ago
Dublin, Ireland Construction Specialist Recruitment Full timeCivil Foreman- Dublin Our client a leading Civil Contractor with over 20 years of experience in Ireland and the UK are seeking a dedicated individual with experience in managing groundwork projects to join their team in Dublin for a project valued at €3 million. This will involve drainage ducting and curbing Responsibilities: - Oversee and manage all...
-
Dublin, Ireland Viatris Full timeMcDermott 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...
-
Fit-Out Site Manager
1 month ago
Dublin, Ireland Construction Specialist Recruitment Full timeFit-Out Site Manager Our are currently looking for a dedicated Site Manager to lead the fit-out of a prestigious hotel project in Dublin. As the Site Manager, you will play a crucial role in ensuring the successful completion of the hotel fit-out, overseeing all on-site activities with a focus on quality, efficiency, and client satisfaction. Key...
-
Project Manager
3 weeks ago
Dublin, Ireland Construction Specialist Recruitment Full timeJob Opportunity: Project Manager Location: South Dublin, Ireland Sector: Residential Development Project: Large-Scale Residential Development Employment Type: Full-Time, Fixed-Term Contract (Project Duration) Salary: Competitive, Commensurate with Experience Start Date: Immediate About the Role: We are seeking a highly skilled Project Manager to oversee the...
-
Site Manager
1 month ago
Dublin, Ireland Construction Specialist Recruitment Full timeFit-Out Site Manager Our client with over 60 years of experience in fit-outs and currently hiring for an experienced Fit-outs Site manager ideally with a trade background for a 4-story government building fit-out in Dublin with a small amount of refurb work. Responsibilities: - Oversee and manage all on-site activities for fit-out projects in Dublin -...
-
Project Manager
1 month ago
Dublin, Ireland Construction Specialist Recruitment Full timeProject Manager Fit-out Our client a leading fit-out contractor currently have an opportunity or a Fit-out site manager to join their team for a range of shop fit-out projects across Dublin. The Role Our client delivers sustainable work environments and empower their staff to achieve their ambitions. They bring the most suitable people together, matching...
-
Senior Specialist, Quality Compliance Global API
5 months ago
Dublin, Ireland Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Site Manager
3 weeks ago
Dublin, Ireland Construction Specialist Recruitment Full timeJob Opportunity: Site Manager Location: Dublin City, Ireland Sector: Government Contracts & Large-Scale Projects Project Value: Up to €10 Million+ Employment Type: Full-Time, Permanent Salary: Competitive, Based on Experience, with Comprehensive Benefits Package Start Date: Immediate About the Role: We are working with a well renowned main contractor...
-
Fit-out Project Manager
1 month ago
Dublin, Ireland Construction Specialist Recruitment Full timeFit-out Project Manager Our client an innovative forward-thinking company with the flexibility to undertake all types of construction projects is seeking an experienced project manager for a hotel fit-out and with a €3 million value lasting 6-8 months in Dublin. This is a permanent role with a strong pipeline of work. The Role To be a positive and...
-
Power Quality Specialist Development
6 months ago
Dublin, Ireland ESB Full timePosition Description The Power Quality Technical Specialist is a leader in his/her specialised field providing technical advice and support to ESB's Distribution, Transmission and Generation businesses as well as providing consultancy services about power quality concerns to external and international customers. He/she is responsible for the timely...