Tipperary, Ireland | Posted on 05/23/2025
* 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 employment contract, providing exposure to top pharmaceutical client sites in a diverse, multicultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We offer unparalleled career development through in-house training, mentorship, and continuous guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations regarding quality, staying within budget, and meeting timelines.
Overview:
The Quality Specialist – Quality Systems supports activities in both the Drug Substance and Drug Product facilities. The role involves participating as a member of the Quality Systems Team.
Requirements
Role Functions:
* Ensure timely and effective completion of the Quality Systems core functions according to schedules, policies, procedures, and guidelines, including subsystem ownership responsibilities as per the site System Ownership list.
Quality SME for Process, Cleaning, Water, Equipment
* Provide leadership through knowledge regarding validation standards for pharmaceutical facilities (SDI & OSD), supporting site committees, approving validation documentation, and ensuring compliance.
Quality SME for Change Control:
* Serve as the principal Quality contact for all site change requests impacting processing, ensuring compliance throughout the change control process.
Laboratory QA oversight:
* Support and approve laboratory systems, instrumentation, and investigations, including documentation review.
Stability oversight:
* Review and approve stability reports, liaise with microbiologists for microbial issues.
Quality Agreement System Management:
* Manage Quality Agreements, ensuring they are current, approved, and properly documented.
Annual Review System Management:
* Oversee completion of Annual Reviews for products and systems.
Creation, review, and approval of Site Quality documentation:
* Manage documents like Site Master File, Validation Master Plan, policies, and procedures.
Quality Oversight of site application User Access Reviews:
* Approve access reviews, ensuring compliance.
Quality Council:
* Manage schedule, agenda, minutes, and follow-up actions for the annual quality council meetings.
Supplier Change Evaluations - Quality Role:
* Review and approve supplier change documentation, generate technical agreements.
Supplier and Customer complaints:
* Participate in investigations and reviews of complaints, ensuring timely responses.
Filing & Licence maintenance and Regulatory Requests follow-ups:
* Maintain site licenses and support product filings.
QA Regulatory Data:
* Review documentation for regulatory submissions, ensuring data integrity.
Returned Goods:
* Manage segregation and disposition, support GMP audits, and host regulatory inspections.
Special Features:
* Work as part of a self-directed team, monitor performance metrics, participate in departmental initiatives, and promote GMP awareness.
Experience, Knowledge & Skills:
Technical:
* Knowledge of GMP standards, validation principles, plant procedures, equipment, and documentation.
Business:
* Demonstrate core values, proficiency in MS Office, report writing, problem-solving, decision-making, and teamwork skills.
Leadership:
* Strong communication, proactive planning, interpersonal skills, and team leadership capabilities.
Qualifications & Education:
* Minimum of a Degree or postgraduate qualification in Science, Pharmacy, or Engineering.
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