Quality Assurance Associate
Based in Cork, our client is a global pharmaceutical company focused on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
They require a Quality Assurance Associate with a minimum of 5 years’ experience in a cGMP regulated FBDS, drug product manufacturing and/or packaging environment is a pre-requisite for application, with exhibited knowledge or proficiency in Quality Assurance and Compliance, to join them, initially on a 23-month contract.
Job Reference: BBBH 21556
What will a Quality Assurance Associate do?
- Assist with quality oversight of the supply chain, manufacture, and packaging of products in various contact Manufacturing Organizations.
- Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending final batch release.
- Review and approve standard operating procedures, master batch records and product specifications.
- Provide Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
- Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.
- Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
- Assist with regulatory requests and inspections.
- Artwork review and approval.
- Assist with new market launches.
What does the Ideal Candidate look like?
- A minimum of 5 years’ experience in a cGMP regulated FBDS, drug product manufacturing and/or packaging environment is a pre-requisite for application, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- Ability to comprehend technical information related to equipment, manufacturing processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
Benefits?
- 20 days annual leave (pro-rata) plus paid bank holidays. Competitive Salary.
- Flexibility for working from home.
- State of the art modern office.
- Work Laptop, phone (most roles), and latest tools and technologies.
- Expanding workforce with options for permanent positions and career progression for top performers.
- The experience of working with a company that will make your CV stand out from the crowd.
Still interested in this opportunity?
Submit your CV (in a Microsoft Word format) today!
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