Quality Assurance Specialist
About the role
Job Information
Date Opened
07/22/2026
Job Type
Full time
Industry
Pharma/Biotech/Clinical Research
Work Experience
4-5 years
City
Dublin
State/Province
Dublin
Country
Ireland
Job Description
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.
Requirements
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 Commissioning and Qualification lifecycle documents for capital projects and new equipment.
QA support, review, and approval for Performance qualification (PQ) & Process Validation activities across site.
Support sustaining and QC activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance and 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.
Technical:
Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Qualifications:
General Competencies:
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.
Demonstrated analytical aptitude, critical thinking skills and problem-solving skills.
Minimum Education/Experience:
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.
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