Senior Quality Assurance Analyst

Posted 15 May 2023
LocationCounty Westmeath
Job type Permanent
Discipline ManufacturingQuality & Laboratory
Contact NameOliver Hayes

Job description

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.  

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