QA Operations Specialist

PE Global; Leinster; On-site; EUR 65,000 - 80,000; Full time

Job summary

PE Global is recruiting for a QA Operations Specialist in Meath. The role supports clinical and commercial operations at the Dunboyne facility, driving quality, EHS, learning and continuous improvement while ensuring cGMP compliance.

You will liaise with site teams to resolve issues, manage quality systems, and ensure timely escalation when needed. A 11-month onsite contract with strong problem-solving focus is offered.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in biotechnology/pharmaceutical industry.
• Experience with deviation management/change controls.
• Knowledge of cGMP regulations and quality systems.

Responsibilities

• Provide QA oversight to clinical and commercial operations at the facility.
• Support quality management systems, CAPAs and change controls.
• Coordinate with Manufacturing Operations, MS&T and Engineering for daily operations.
• Ensure timely disposition of commercial Drug Substance and regulatory approvals.
• Represent Quality on multidisciplinary teams and drive continuous improvement.

Skills

QA oversight

Deviation management

Change controls

Batch Record Review

cGMP

Decision making

Teamwork

Initiative

Flexibility

Education

Science/Pharmacy degree

Job description

PE Global is currently recruiting for QA Operations Specialist on behalf of a leading company based in Meath.

This is an initial 11-month contract role. This is onsite role.

Batch record review or deviation (investigation) experience

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

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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:

In order to excel in this role, you will more than likely have:

• 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.
• 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.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***