QA Operations Specialist

Life Science Recruitment; Leinster; On-site; EUR 70,000 - 90,000; Full time

Job summary

Life Science Recruitment is recruiting for an award-winning pharmaceutical organisation based in Louth. The role will oversee QA for clinical and commercial operations across the biotech facility, driving quality, EHS, learning, and continuous improvement in line with cGMP regulations.

You will collaborate with Manufacturing Operations, MS&T, and Engineering to resolve issues, execute quality systems, manage CAPAs, change controls, deviations, and batch documentation review, ensuring regulatory

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in biotechnology/pharmaceutical industry.
• Previous experience with deviation management/Change controls.
• Previous experience in Batch Record Review is preferable.
• Knowledge of cGMP regulations both domestic and international.

Responsibilities

• Provide QA oversight to 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.
• Support the execution of an effective Quality system and accountability for quality management systems (CAPAs, Change Controls, Deviations, Batch Documentation Review).
• Liaises with internal partners to support daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensure clear communication on issues and timely escalation as applicable.
• Maintain site practices and procedures related to clinical and commercial operations.
• Adhere to domestic and international GMP regulations, cGMPs, company policies, leadership behaviours, and performance and budget management.
• Champion site metrics to ensure targets are achieved with counter measures.
• Represent Quality on multidisciplinary teams and execute company policies.
• Ensure new/revised quality system requirements are deployed to the Site.

Skills

QA oversight

cGMP compliance

Change controls

Deviation management

Batch documentation review

Regulatory approvals

Quality systems

Problem solving

Education

Science/Pharmacy degree

Job description

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Louth. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role will be responsible for supporting the clinical and commercials operational activities, 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.

Key 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 (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 behaviours, 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

Education and Experience:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in the biotechnology and/or pharmaceutical industry.
• Previous Experience with deviation management/Change controls
• Previous Experience in Batch Record Review is preferable
• Knowledge of cGMP regulations both domestic and international.