Quality Specialist

3 weeks ago

Dublin, Ireland PSC Biotech Corporation Full time

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 points 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 to 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 through 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.
- Provide 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 ensure 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.
- Provide support to internal audits and regulatory inspections.
- Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.

Qualification and Experience:

- 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 in 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.
- Bachelor's 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.

#J-18808-Ljbffr

  • Quality Specialist

    3 weeks ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    Quality Specialist - Life Science - 11-Month Contract - ClonmelOur Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Clonmel for over 40 years, exports to over 25 countries around the world with...

  • Quality Specialist

    3 weeks ago

    Dublin, Ireland TN Ireland Full time

    Quality Specialist - Life Science - 11-Month Contract - ClonmelOur Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Clonmel for over 40 years, exports to over 25 countries around the world with...

  • Quality Specialist

    1 week ago

    Dublin, Dublin City, Ireland ICDS Group Full time

    Quality Specialist - Dublin city centre. In this role you will be: Responsible for development of quality systems based on business, regulatory and customer requirements. Lead and participate in quality systems and engineering improvement initiatives, with specific focus on supply chain performance. Utilise industry and process excellence standards in daily...

  • Quality Manager Dublin

    7 days ago

    County Dublin, Ireland Construction Specialist Recruitment Full time

    Job Role: Quality Manager Dublin The CSR Group has been retained by one of Irelands leading Main Contractors who Operate across Ireland and the UK.This Company is looking to take on a Quality Manager that is well experienced and knowledgeable within the construction industry.The Project is a €300+ million project on the East of Dublin which is approaching...

  • Quality Specialist

    7 days ago

    Dublin, Ireland Psc Biotech Corporation Full time

    About 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 Regulatory...

  • Quality Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland ICDS RECRUITMENT CONSULTANTS LTD Full time

    Quality SpecialistThis is a role where you will be responsible for the development of quality systems based on business, regulatory and customer requirements.Key Responsibilities:Develop quality systems aligned with business, regulatory and customer needs.Lead and participate in quality improvement initiatives, focusing on supply chain performance.Apply...

  • Quality Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland ICDS Recruitment Full time

    Job Description Quality Specialist - Dublin 12/hybrid Ref No: DT18246x County Dublin, Republic of Ireland Competitive salary Quality Specialist - Dublin 12/hybrid Role Overview: As a Quality Assurance Specialist, your primary duties will revolve around maintaining and enhancing the quality systems to ensure compliance with industry...

  • Facilities Services Specialist

    3 weeks ago

    Dublin, Ireland Construction Specialist Recruitment Full time

    Facilities Services Specialist - Dublin - Construction Specialist RecruitmentJob title: Facilities Management SpecialistDescriptionJob OverviewWe are seeking an experienced Facilities Management Specialist to join our team at Construction Specialist Recruitment. As a key member of our team, you will be responsible for delivering our major healthcare facility...

  • Facilities Operations Specialist

    3 weeks ago

    Dublin, Ireland Construction Specialist Recruitment Full time

    Facilities Operations Specialist - Dublin - Construction Specialist RecruitmentJob title: Facilities Services SpecialistDescriptionJob OverviewOur company is seeking an experienced facilities operations specialist to deliver our major healthcare facility project in Dublin.Job Responsibilities:Oversee all aspects of the fit-out process, ensuring quality,...

  • Quality Specialist

    1 week ago

    Dublin, Dublin City, Ireland Psc Biotech Full time

    Job DescriptionAbout 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...

  • Quality Specialist

    7 days ago

    Dublin, Ireland Psc Biotech Full time

    Job DescriptionAbout 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...

  • Facilities Management Specialist

    3 weeks ago

    Dublin, Ireland Construction Specialist Recruitment Full time

    Facilities Management Specialist - Dublin - Construction Specialist RecruitmentAs a Facilities Management Specialist, you will play a pivotal role in delivering our client's major healthcare facility project in Dublin. You will be responsible for overseeing all aspects of the fit-out process, ensuring quality, safety, and timely completion.Key...

  • Workplace Safety Specialist

    3 weeks ago

    Dublin, Ireland Construction Specialist Recruitment Full time

    Workplace Safety Specialist - Dublin - Construction Specialist RecruitmentCrescent Specialist Recruitment is a specialist recruitment agency operating in the construction sector.We work closely with leading Main Contractors to provide high-quality recruitment solutions that meet their needs.Our team is dedicated to finding the best candidates for our...

  • Quality Specialist

    3 weeks ago

    Dublin, Ireland PSC Biotech Corporation Full time

    About 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 Regulatory...

  • Quality Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    About 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 Regulatory...

  • Quality Assurance Specialist

    1 day ago

    Dublin, Dublin City, Ireland Dole UK Ltd Full time

    We are seeking a highly skilled Quality Assurance Specialist to join our team at Dole UK Ltd. The role of the Quality Assurance Specialist will involve ensuring that all fresh produce meets the highest standards possible.Key responsibilities include:Conducting quality inspections at various points within our production processMaking informed decisions based...

  • Contract Management Specialist

    3 weeks ago

    Dublin, Ireland Construction Specialist Recruitment Full time

    Contract Management Specialist - Dublin - Construction Specialist RecruitmentJob title: Contract Administration SpecialistDescriptionContract Administration Role - DublinWe are looking for a skilled Contract Administration Specialist to join our team at Construction Specialist Recruitment.Responsibilities:Contract administration and management.Stakeholder...

  • Quality Assurance Specialist

    1 week ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    Quality 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 Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Barden Full time

    Barden are delighted to be supporting our Global Pharmaceutical client in their search for Quality Specialist for their state-of-the-art facility in Dublin.ABOUT THE ROLE:This is an initial 9-month contract, on a hybrid basis of 3 days onsite and 2 days remote. You will report into the Director of Supplier Quality and will be primarily responsible for...

  • Project Delivery Specialist

    3 weeks ago

    Dublin, Ireland Construction Specialist Recruitment Full time

    Project Delivery Specialist - Dublin - Construction Specialist RecruitmentJob Overview:We are currently seeking a skilled Project Delivery Specialist to join our operations team at Construction Specialist Recruitment. This exciting opportunity presents a chance to contribute to the success of a leading Irish civils contractor in the construction...