Overview
Quality Specialist Jobs in Dublin, County Dublin, Ireland at PSC Biotech® Corporation
Title: Quality Specialist
Company: PSC Biotech® Corporation
Location: Dublin, County Dublin, Ireland
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:
This is a shift role (4 x 12hr extended days followed by 4 days off).The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.
The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, 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 first time, and to ensure compliance with cGMPs and regulatory requirements.
Requirements
Role Functions:
- Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
- Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
- Provides presence on the shop floor to support compliance and data integrity
- Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
- Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
- Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
- Participates as the quality member on cross functional projects
- Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
- 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
- Drive continuous improvement and utilise problem solving tools . Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues
Experience, Knowledge & Skills
- Required Minimum 5 years of relevant post-degree experience in GMP Manufacturing, Quality Assurance, Laboratory, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory functions supporting manufacturing or laboratory operations Proven experience in the biotech/pharmaceutical industry, with strong working knowledge of QA operations and exposure to regulatory agency interactions preferred
- Strong understanding of cGMPs and applicable global regulatory requirements
- Demonstrated leadership capabilities with effective oral and written communication skills
- Strong interpersonal skills, including flexibility, collaboration, and ability to work effectively in a team environment
- Conduct routine audits of data, procedures, equipment, systems (including computerized systems), and facilities to ensure compliance with SOPs, GMPs, and global regulations
- Perform audits/inspections independently (under supervision) or as part of a team to assess compliance with internal and external standards
- Prepare audit reports, clearly documenting observations, deficiencies, and compliance status
- Review and approve production and analytical documentation supporting the release of API, safety assessment, and clinical supply lots (bulk and packaged)
- Ensure all documentation meets regulatory and quality requirements prior to product release
- Communicate audit findings and work with relevant stakeholders to resolve audit observations
- Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA)
- Escalate critical findings and inspection outcomes to appropriate management
- Operate with moderate supervision, demonstrating strong competence and sound judgment in quality auditing processes
Preferred:
- Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
- Demonstrated analytical aptitude, critical thinking skills and problem-solving skills
- Demonstrated ability to upskill/coach others
- Experience working on manufacturing shop floor
- Familiarity with GMP documentation review and/or shop floor auditing
Qualifications & Education:
- Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience
