QA Specialist – Meath

Desired Skills: batch release,deviation,qa specialist

The role:

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 apply today.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net

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