QA Operations Specialist, Biotech (cGMP, Batch Review)

PSC Biotech Ltd; Dunboyne; On-site; EUR 55,000 - 75,000; Full time

Job summary

PSC Biotech Corporation in Dunboyne, Ireland, seeks a QA Operations Specialist for an 11-month contract. The role supports clinical and commercial operations, batch review, and regulatory compliance in a multi-product facility. You will collaborate across site teams to uphold quality and process improvements.

Requirements include a science/pharmacy degree and at least 3 years in biotech/pharma, with experience in batch record review, deviations, and cGMP. Remote/hybrid options not specified.

Qualifications

• 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.
• Possess strong problem solving and troubleshooting skills.

Responsibilities

• 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 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.

Skills

Biotech/pharma experience

Batch record review

Change control

cGMP knowledge

Problem solving

Teamwork

Working under pressure

Education

Science or Pharmacy degree

Job description

PSC Biotech Corporation in Dunboyne, Ireland, seeks a QA Operations Specialist for an 11-month contract. The role supports clinical and commercial operations, batch review, and regulatory compliance in a multi-product facility. You will collaborate across site teams to uphold quality and process improvements.

Requirements include a science/pharmacy degree and at least 3 years in biotech/pharma, with experience in batch record review, deviations, and cGMP. Remote/hybrid options not specified.