QA Specialist

QA Specialist

Our client specialises in the development, optimization and manufacturing of high quality generic Active Pharmaceutical Ingredients.  They are currently seeking to recruit a QA Specialist in order to sustain their growth.

 

The chosen candidate will be responsible for:

• 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;
• Verifying internal and external equipment qualifications;
• Participating in client and regulatory audits, as well as carrying out internal audits; and,
• Managing and participating in training activities.

 

The ideal candidate will:

• Be in possession of a MQF Level 6 in Chemistry (ideally Organic) or Pharmacy;
• Experience with the pharmaceutical industry and familiar with Good Manufacturing Processes and FDA quality metrics; and,
• Have good communication and written skills in English and preferably Italian.

 

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