The Role:
We are seeking a highly skilled QA Senior Specialist to join our team. The ideal candidate will have a strong background in quality assurance and excellent communication skills.
Main Responsibilities:
* Collate site quality metrics, monitoring trends with actions, and reporting findings.
* Lead monthly Site Quality Management Reviews to ensure compliance and drive improvement.
* Oversight of supplier qualification to ensure adherence to regulatory requirements.
* Back-room lead for all customer audits and regulatory inspections, ensuring seamless execution and compliance.
* Part of the internal Audit team on site, contributing to the development and implementation of audit plans.
* Main point of contact for all licensing, including HPRA ASR, scheduled substances, PMDA, and other regulatory requirements.
* Assist with Assessment and QA Approval of changes for GMP compliance in accordance with change control procedure for facilities, utilities, lab, and manufacturing equipment and control system changes (where required).
* Review and approval of GMP SOPs (where required), ensuring compliance and effectiveness.
About Us:
We are a leading Contract Development and Manufacturing organization (CDMO) with state-of-the-art facilities globally. Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
Key Requirements:
* A Bachelor's or Master's degree in Chemistry or a related scientific field is required, with a minimum of 3 years of experience in the pharmaceutical industry in a similar role.
* Strong initiative and ability to work independently and collaboratively across the organization.
* Demonstrated characteristics aligned with SK pharmteco Values and Behaviors.
Desired/Advantageous:
* Previous experience in QA Systems generating Site Quality Metrics.
* Previous experience in Supplier Qualification.
* Experience in Clinical to commercial manufacturing.
* Lean Six Sigma – proven track record improving Systems processes e.g. Metric generation, Supplier Qualification and/or Digitalisation.
* Experience in back room for regulatory inspections or part of Inspection readiness team.
Benefits:
* Excellent opportunities for career enhancement and personal development.
* Competitive base salary.
* Annual bonus linked to business results.
* A well-established further education program.
* Pension scheme.
* Private healthcare.