Job Description
The Siegfried Group is a Swiss-based worldwide life science company which develops and manufactures active pharmaceutical ingredients, intermediates, standard controlled substances, and ready-formulated drugs.
Forming part of the Siegfried Group, Siegfried Malta Limited specialises in a high-value and innovative generic portfolio in the solid dosage form range, from bulk to final packaging including capsule filling and high potent FDA approved products.
Position Summary
We are seeking to recruit a QA Senior Specialist who will be responsible for Investigations & CAPAs, including the overall coordination of the respective section.
The chosen candidate will be responsible for:
- Managing investigation reports and CAPAs, ensuring accurate, complete, logical, and well-documented investigations whilst verifying that the scope of the investigation and root cause analysis are adequate;
- Coordinating the overall CAPA management by providing guidance to other departments during investigations, working closely with customers, CAPAs implementation and monitoring applications in liaison with QA managers;
- Ensures that state of the art root cause (fishbone, 5 why’s etc.) analyses are performed and that the documentation of this actions are GMP compliant;
- Maintaining CAPA databases such as Excel and eventually Trackwise;
- Gathers and analyses data in support of investigations and trend analysis;
- Approves DR and CAPA on behalf of the QP;
- Participates in customer and regulatory audits from a CAPA management system standpoint.
The ideal candidate should possess:
- A Bachelor’s degree in Life Science or other job-related discipline;
- Previous experience in CAPA management within a pharmaceutical industry environment;
- Proficiency and aptitude for computer systems and software;
- Experience in root cause analysis, investigations, technical / report writing, and extensive knowledge of quality systems;
- Strong interpersonal and communication skills.
