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
