QA Specialist

PSC Biotech® Corporation; Dunboyne; On-site; EUR 50,000 - 75,000; Full time

Job summary

PSC Biotech Corporation seeks a QA Operations Specialist to support clinical and commercial operations at our Ireland facility. The role focuses on batch record review and release, ensuring strict adherence to cGMP and regulatory requirements.

You will work with site teams to resolve issues, maintain QA systems, and drive continuous improvement in quality, EHS, and training. This is an 11-month contract offering exposure to top pharmaceutical clients.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.

Responsibilities

• Provide QA oversight to clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing.
• Support process technical transfers and analytical transfers, drug substance disposition and regulatory approvals.
• Maintain QA systems (CAPAs, Change Controls, Deviations, Batch Documentation).
• Liaise with internal partners to support daily operations and ensure on-time disposition of commercial Drug Substance.
• Ensure adherence to domestic and international GMP regulations and company policies.
• Represent Quality on multidisciplinary teams and drive continuous improvement.

Skills

QA oversight

Batch record review

cGMP compliance

Problem solving

Team collaboration

Regulatory knowledge

Documentation

Education

Degree in Science/Pharmacy

Job description

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.

About PSC Biotech

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

Job Purpose:

• An amazing opportunity has arisen for a QA Operations Specialist. This role will be responsible for supporting the clinical and commercials operational activities and batch record review and release, at the single use multi-product biotech facility. You will work across site teams to resolve issues and drive quality, EHS, learning, and continuous improvement, while ensuring compliance with cGMP and corporate regulations.
• 11 Month of Contract

Requirements

What you will do:

• Provide QA oversight to the clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• Liaises with internal partners (e.g. Manufacturing Operations, MS&T, Engineering functions etc) in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Helps maintain site practices and procedures related to clinical and commercial operations.
• Responsibility for adhering to domestic and international GMP regulations, cGMP's, company policies, leadership behaviors, and performance and budget management.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Representing Quality on multidisciplinary teams.
• Executing company policies.
• Ensures new/revised quality system requirements are deployed to the Site.
• Ability to work on his/her own initiative in addition to working as part of a team
• Possess strong problem solving and trouble shooting skills

What skills you will need:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years' experience in the biotechnology and/or pharmaceutical industry.
• Previous Experience in Batch Record Review and Manufacturing Operations is preferable
• Previous Experience with deviation management/Change controls is preferable
• Knowledge of cGMP regulations both domestic and international.
• Proven decision-making capability with full accountability and responsibility.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Flexible and self-motivated.