What you need to know

​A new and pioneering Irish pharmaceutical company who are involved in the research, development and production of active pharmaceutical ingredients that will be exported globally, is seeking a Senior Quality Assurance Analyst to join their quality team in Co. Westmeath.

The company is going through a period of substantial growth and has secured interest in its products from several large and reputable pharmaceutical companies. This is an exciting opportunity for a quality professional to work in a dynamic and fast-paced environment, where they will be challenged and offered the chance to broaden their skill set and take on extra responsibility.

As a Senior Quality Assurance Analyst, you will be responsible for overseeing the development, implementation and maintenance of quality assurance policies, procedures and systems that comply with industry regulations.

This a full-time permanent position with an excellent salary and package.

Your new job 

Duties and responsibilities:

• Work with the quality team and management to develop, implement, and maintain the Quality Management System (QMS) in accordance with industry standards and regulatory requirements.

• Oversee change control, deviation, and corrective and preventive action (CAPA) processes, ensuring proper documentation, investigation, and resolution.

• Review and approve validation and qualification documents, including cleaning, process, and analytical validation, as well as equipment and facility qualifications.

• Perform routine audits of manufacturing processes, facilities, and quality systems to ensure compliance with GMP and other relevant standards.

• Collaborate with cross-functional teams to identify and resolve quality-related issues and drive continuous improvement initiatives.

• Train and mentor junior quality assurance staff and other team members on quality standards, procedures, and best practices.

• Review and approve API batch records, laboratory data, and other documentation to ensure that finished products meet the required specifications and quality standards.

• Stay up to date with industry trends, regulatory changes, and best practices to ensure ongoing compliance and continuous improvement.
  

What are we looking for? 

• Bachelor’s degree in chemistry, pharmaceutical sciences, or another relevant field or a Master’s in a relevant discipline. 

• A minimum of 5 years of experience in quality assurance within the pharmaceutical or API manufacturing industry, with a proven track record of success.

• In-depth knowledge of GMP, ICH guidelines, and other relevant regulations and quality standards applicable to API manufacturing.

• Strong analytical, problem-solving, and decision-making skills.

• Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

• Possess excellent attention to detail with strong organisational and time management skills.

• Proficient in the use of MS packages and relevant quality management software.

​

Interested in this position? 

Apply for this job now by sending a Word version of your CV via the link above.  

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and consent.

 We Value Your Trust