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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