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Quality Manager

  • Sector: Science & Pharma
  • Contact Email: davin.ferguson@collinsmcnicholas.ie
  • Job Ref: 19067

Quality Manager Longford


Do you want to join a company in the midlands which is one of the world’s leading suppliers of health care products and is in the Top 20 ranking of Medical Devices Companies? This company is also recognised as a Great Place To Work in Ireland and one that has a mission to become the most progressive company in the life sciences industry.


Position Overview:

The Quality Manager has the responsibility to ensure that all product manufactured is done so in a manner compliant with all appropriate procedures, regulations and guidelines. This role will report to the Site Director


Principal Duties and Responsibilities:

·        Lead all QM-Activities on site and ensure GMP, GLP, and GDP is adhered to at all times.

·        To ensure that company policies, procedures specifications are adhered to at all times.

·        To ensure that all necessary testing is carried out and the associated records evaluated.

·        Qualified Person for the releasing of batches

·        To approve specifications, sampling instructions, test methods and other quality control procedures.

·        Lead and monitor the Environmental Monitoring programme

·        Compile and monitor the key quality indicators at the site

·        Lead, support and provide development opportunities to quality employees on site.

·        Lead the laboratory operations within the plant

·        Ensure adequate delegation and monitoring of key tasks to Quality staff.

·        Lead regulatory inspections with relevant authorities at the site

·        Complete periodic reviews of the company’s systems and processes

·        Ensure regulatory compliance requirements are met

·        Ensure regulatory CAPA are kept up to date and delivered on time.

·        To approve and monitor any contract analysts

·        To ensure the qualification and maintenance of her / his department, premises and

·        equipment.

·        To ensure that the appropriate validations are done

·        To ensure that the required initial and continuing training of her / his department personnel is carried out and adapted according to need.

·        The authorisation of written procedures and other documents, including amendments

·        The monitoring and control of the manufacturing environment


Qualifications & Experience:

·        At least 5 years work experience as a Manager within Quality in a Pharmaceutical regulated industry

·        A QP qualification is desired

·      Has an understanding of the needs of a global acting company, regarding structures, decision making time and ability and willingness for standardisation and harmonization between the several sites

·        A level 8 degree in a Quality, Science or Engineering discipline

·        Authentic leadership aligned with the core company values to enable the pursuit of excellence.

·        Collaborative Team Player with good interpersonal skills

·        Strong Communication Skills

·        Show Resilience, be Flexible and Adaptable

·        Promote understanding of regulations and standards and their practical implementation to the sites

·        Professional level written and oral communication skills

·        An understanding of SAP an advantage


For a confidential discussion and more information on the role, please contact Davin Ferguson.

davin.ferguson@collinsmcnicholas.ie

071-9140251