Quality Assurance Specialist

Our client, a leading manufacturing client within the pharmaceutical industry are looking for a QA Specialist  who will be responsible for ensuring that all our company processes are in compliance with cGMP practices. This position is on a full-time basis and on day shift.

The Position Requires:

• Experience working in a GMP environment
• Maintaining the quality standard policy and ensuring it is aligned to corporate, FDA and Malta Medicines Authority guidelines
• Working closely with production and quality control departments to ensure abidance to cGMP
• Managing all deviations and carrying out thorough investigations applying root-cause analysis and compiling relevant reports in accordance with strict timelines
• Constantly liaising and communicating with management regarding all GMP related investigations
• Managing CAPAs and monitoring their effectiveness
• Managing change requests applying the procedures in force, respecting agreed timelines
• Compiling and reviewing of various GMP-related procedures, protocols and reports
• Updating or elaboration of Specifications and Test Methods
• Verification of internal and external equipment qualifications
• Participating in client and regulatory audits, as well as carrying out internal audits

Skill-sets and Requirements

• Knowledgeable in conducting quality investigations, root cause analysis and quality risk assessments
• Familiar with Good Manufacturing Processes and FDA quality metrics
• Proficient in the use of Microsoft Office (Word, Excel)
• Proficient in English and ideally Italian
• Diligent, self- motivated and with good attention to detail
• Able to handle pressure and shifting priorities and remain focused when problems arise

Education & Experience

• In possession of a scientific degree or diploma
• Experience within the pharmaceutical industry

Benefits

• Health Insurance
• Performance Bonus

Job Reference: IE730