Job Title: Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to support our client's Quality Management System in their Pharma related manufacturing company in Laois, Ireland.
This is an excellent opportunity for a motivated professional with experience in the Pharmaceutical GMP environment to join a well-established and respected company.
About the Role:
* Manage day-to-day activities to ensure compliance to the established Quality Management System.
* Support product realization in a GMP environment.
* Manage, update, and communicate monthly metrics.
* Implement revised quality metrics.
* Manage the Corrective and Preventative action (CAPA) and deviation processes.
* Co-ordinate deviation investigations.
* Support SMEs in addressing findings.
* Mentor Quality Assurance associates.
* Manage internal Audit program.
* Lead monthly quality audits of each area.
* Ensure controlled areas operate to the required standards.
* Actively participate and implement continuous improvement initiatives.
* Provide support and expertise for inspection readiness.
* Update internal procedures as appropriate.
* Support customer and regulatory audits.
* Support projects as required.
* Provide regular updates to the Quality Supervisor.
Requirements:
* Bachelor's Degree in a Science Related Discipline.
* Min 6 years' experience Pharmaceutical GMP environment, desirable.
* Good knowledge of current regulatory requirements and working knowledge of ISO 9001:2015 is required.
* Knowledge EXCiPACT and IPEC regulations an advantage.
* Experience in Quality Risk management.
* Desired competencies include strong attention to detail focused on delivery of a Quality product.
* Good organizational and presentation skills, ability to communicate Quality Metrics to management.
* Strong interpersonal and communication skills, ability to maintain positive, Quality focused relationship with internal and external stakeholders.
* Excellent Written and oral communication skills.
* Strong leadership and conflict resolution skills.
* Ability to foster collaborative, cross department relationships to meet common objectives.
Salary:
The estimated salary for this role is €60,000 - €80,000 per annum, depending on experience.
Please note that this is a competitive market rate and may be adjusted based on individual circumstances.