A pharmaceutical company is seeking an eligible Qualified Person to join their QA team in Malta reporting to Reporting to the QA Operations Manager. The candidate will be responsible for the compliant certification and release of medicinal products and for supporting effective site quality oversight and continuous improvement.
Responsibilities:
Oversee and actively participate in the batch release and certification process, ensuring that all required documentation is complete, accurate, and compliant prior to release.
Serve as the primary quality contact for assigned clients, addressing quality-related matters, deviations, and product complaints in a timely and compliant manner.
Perform review and approval of validation- and GMP-related documentation, including change controls, deviations/non-conformances, and CAPAs, ensuring appropriate risk assessment and regulatory impact evaluation.
Lead or support internal and external audits, as well as regulatory inspections including preparation, execution and follow-up activities.
Provide technical guidance and oversight to Quality, Production, Warehouse, and Supply Chain functions to ensure ongoing compliance with quality systems, procedures, and regulatory expectations.
Contribute as a site subject matter expert to local and global Quality initiatives, supporting projects, continuous improvement activities, and product launches , as required.
Perform additional QA-related activities within the Operations, Systems or Validation functions, aligned with business exigencies and the candidate's expertise.
Requirements:
A tertiary-level degree in a relevant scientific discipline
Demonstrable experience performing QP duties within a GMP-regulated pharmaceutical manufacturing environment.
Strong problem-solving skills, including the ability to analyse quality issues, identify root causes, and propose and support effective, compliant solutions.
Pharmacist qualification and/or experience as a Responsible Person (RP) will be considered an asset.
Communicating clearly and concisely, both orally and in writing across multiple levels of the organisation.
