Tipperary, Ireland | Posted on 05/20/2025
* Industry Pharma/Biotech/Clinical Research
* Work Experience 1-3 years
* 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 over 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, providing 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, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients’ expectations regarding quality of all scalable and business unit deliverables, staying under budget, and meeting deadlines.
Overview
The Quality Specialist – Quality Systems supports activities in both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team.
Requirements
Role Functions:
* The incumbent ensures timely and effective completion of the Quality Systems core functions in accordance with schedules, policies, procedures, and guidelines, including:
* Complete subsystem ownership responsibilities as per the site System Ownership list.
Quality SME for Process, Cleaning, Water, Equipment
* Provide leadership through knowledge and skills regarding validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
* Participate in and support site validation committees (PVC, WVC, CVG, EQVC).
* Approve validation documentation and ensure compliance with policies, procedures, and guidelines.
* Support site or capital project validation requirements and provide technical assistance.
* Develop Validation Summary Reports and assist in overall Quality planning for major projects.
* Monitor validation trends and best practices industry-wide.
* SAP Quality Process Steward.
Quality SME for Change Control:
* Serve as the principal Quality contact for all site change requests impacting processing.
* Review change requests through all stages, ensuring compliance and proper documentation.
Laboratory QA oversight:
* Support and approve systems supporting laboratory functions, instrumentation, and GLIMS.
* Oversee laboratory incidents, investigations, and documentation.
Stability oversight:
* Review and approve stability reports, ensuring accuracy and supporting investigations.
* Act as Microbiology Point of Contact for microbial issues.
Quality Agreement System Management:
* Manage the inventory of Quality Agreements, ensuring they are current, approved, and properly stored.
Annual Review System Management:
* Ensure completion of Annual Reviews for products and systems, including automation.
Documentation and Regulatory Support:
* Create, review, and approve site quality documentation.
* Manage site user access reviews.
* Coordinate Quality Council activities.
* Review and approve supplier change evaluations, complaints, and regulatory data.
Additional responsibilities include:
* Managing returned goods, supporting GMP audits, and hosting regulatory inspections.
* Participating in departmental initiatives and cross-functional teams.
* Promoting GMP awareness and ensuring compliance across the site.
Experience, Knowledge & Skills:
Technical:
* Knowledge of GMP standards, validation principles, and plant procedures.
* Understanding of laboratory testing, validation, and system development lifecycle.
Business:
* Strong communication, decision-making, and problem-solving skills.
* Proficiency in Microsoft Office and technical report writing.
Leadership:
* Effective interpersonal and team leadership skills.
* Ability to plan, schedule, and generate ideas.
Qualifications & Education:
* Degree or postgraduate qualification in Science, Pharmacy, or Engineering.
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