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Senior Quality Assurance Specialist

Great opportunity to work as a Senior Quality Assurance Specialist at an innovative biotechnological organization. A unique chance for you to work at a senior level and strengthen your leadership and QA skills.

Job Description:
Are you ready to give your career a much-needed boost? As a senior QA, you be responsible for ensuring the upmost quality of raw materials and finished products. You will not only be servicing an entire business unit with cost-effective strategies but you will also be involved in continuous process improvement. Your aim for the company is to align the company standards with the regulatory requirements.

Responsibilities:

  • Responsible for batch release records, risk assessments, investigations, deviation analysis, CAPA, and root cause analysis.

  • Conform to health & safety regulations and GMP/GLP standards.

  • Perform regulatory audits/inspections (i.e. GMP(+), FDA, ISO F22000).

  • Writing and reviewing protocols and SOPs.

  • Conducting equipment and system qualification and validation.

  • Clearly communicate scientific data to internal and external costumers from various backgrounds.

  • Training of junior staff from the factory, laboratory, and other departments when required.

  • Overseeing the sample management and distribution to QC departments.

  • Staying informed about new technologies and analytical equipment within laboratory services.


Requirements

  • Minimum of 3 years of quality assurance experience in the food, pharma, or chemical industry.

  • Experience working under GMP standards. Working under ICH is a plus.

  • Higher education in biology, chemistry, engineering, or equivalent is required.

  • Experience working with a quality management system (QMS).

  • Direct experience interacting with regulatory agencies such as (IMDRF) or (FDA) is a must.

  • Exceptional communication and interpersonal skills.

Terms:

  • Salary: €3750 - €5400 per month

  • Working hours: Fulltime.

  • Location: County Kerry