Title: CAPA Specialist
Location: North Dublin
Reporting to: Scientific and Medical Affairs Manager
Contract Type:
12 month fixed term contract

Job Description

We are currently recruiting for an experienced CAPA Specialist to join our team in North Dublin. The company has a number of Medicinal products, Medical Devices, Food Supplements and Food for Special Medical Purposes within its internationally marketed product portfolio.
Reporting to the Scientific and Medical Affairs Manager, the CAPA Specialist will be joining the Quality Team and will be responsible for the management and coordination of quality and compliance activities across the company.

This role is also responsible for actively promoting a culture of continuous quality improvement and will involve close collaboration with departments across Supply Chain, Regulatory, Development, Manufacturing Support, Pharmacovigilance and Customer Services. This role provides leadership for regulatory inspections and educates others in the company on all aspects of quality within the company. The key areas of responsibility lie within the areas of the Quality Management System, Quality Assurance & Compliance, Auditing and Quality Improvement Projects.

Key Duties & Responsibilities

Quality Management System

  • Day-to-day management of CAPA’s, Deviations, Change Controls, Complaints, internal audits and vendor approvals.
  • Update and maintenance of Quality documents, such as product specifications, and the preparation and update of SOPs.
  • Ensure that internal and external QA documentation is prepared and completed correctly as per the regulations.
  • Product sample retention system and the document archive system.
  • Monitor and ensure Technical Agreements are in place andmaintained with all relevant suppliers and service providers for out-sourced activities.
  • Final approval of new and revised Technical Agreements.
  • From a Quality perspective ensuring the stability program testing is completed and results are reported on time.
  • Reporting of Quality metrics to the Management Team.

Quality Compliance

  • Maintain and ensure compliance of the Quality Management System with European Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulations for Active Pharmaceutical Ingredients (APIs) and Finished Drug Products, the Medical Device Regulations, ISO 13485 for medical devices and any other relevant guidelines related to the business.
  • Maintain compliance by working closely with the Qualified Person (QP) for medicines and Responsible Person (RP) for GDP as appropriate.
  • Lead Quality Management Reviews and Product Quality Review meetings.

Auditing

  • Ensure that internal and external audit schedules are prepared and adhered to as planned.
  • Ensure all audits are carried out as scheduled.
  • Ensure the timely review, monitoring and reporting of audits.
  • Final approval of self-inspection reports.
  • Ensure follow-up with auditees with satisfactory and timely closure of audit actions.

General

  • Participate / lead internal Quality Improvement Projects relevant to the Quality Management System, Quality Compliance and Quality Assurance.
  • Ensure on-going compliance of the Quality Management System.
  • Perform other quality related tasks as will be required from time to time.

Experience, Skills & Competences

The Successful Candidate will possess the following:

  • 3rd level qualification in a science discipline.
  • 6 to 8 years of experience in the pharmaceutical and/or medical devices industries. Specific experience working in a Quality Assurance and / or a Quality Systems role is a requirement for this position.
  • Minimum of 2 years’ experience in CAPA management is essential for this role.
  • Change Control experience is required for this role.
  • Strong background in the application of ISO 13485, GMP and GDP standards.
  • Experience in regulatory inspections, supplier audits and customer audits.
  • Strong organisational skills, ability to prioritise work and systematic approach to tasks.
  • Accuracy and attention to detail and organisational skills.
  • Highly self-motivated, self-driven and “can-do attitude”.
  • Enjoy and thrive in fast paced environment.
  • The company works with a number of stakeholders both inside and outside the company, the ideal candidate will demonstrate excellent interpersonal, communication and presentation skills, strong analytical and problem solving skills.
  • Applicants must also possess the ability to work well both on their own initiative and have keen soft skills to work within a team (multi-departmental) environment.
  • High level of proficiency in Microsoft Word and Excel.
  • Proficiency in speaking, comprehending, reading and writing English is required.
  • Willingness to travel (approx. 10%).

Advantages:

  • Certified internal and external auditor
  • Project Management Training and Experience
  • Electronic Quality Management System experience

Kora Healthcare offers good benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment. Kora Healthcare is an Equal Opportunity Employer.

Kora Healthcare Values:

  • Passion: “Passion is the difference between great and ordinary”
  • Enjoyment: “Enjoy the journey”
  • Effective: “Together Everyone Achieves More”
  • Courage: “Be the game changer – it’s not about ideas; it’s about making ideas happen”
  • Empowerment: “Honesty and trust is the license to empowerment and responsibility and accountability is the price of empowerment”

To apply for this position: please email cover letter and CV to careers@korahealthcare.com quoting job title in the subject line.