GRS are recruiting a Quality Assurance Specialist on behalf of our fast-growing pharmaceutical client, specialising in the development, optimization and manufacturing of high quality generic Active Pharmaceutical Ingredients (APIs) In this role you will be responsible for ensuring all our company processes are in compliance with cGMP practices. This position is on a full-time basis and on day shift. If you feel you have the necessary experience for this Quality Assurance Specialist Malta based role, send your CV today!
MAIN DUTIES AND RESPONSIBILITIES
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Maintaining the quality standard policy and ensuring it is aligned to corporate, FDA
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and Malta Medicines Authority guidelines.
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Experience working in a GMP environment
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Working closely with production and quality control departments to ensure abidance to cGMP.
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Managing all deviations and carrying out thorough investigations applying root-cause
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Analysis and compiling relevant reports in accordance with strict timelines.
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Constantly liaising and communicating with management regarding all GMP related
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investigations.
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Managing CAPAs and monitoring their effectiveness.
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Managing change requests applying the procedures in force, respecting agreed
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timelines
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Compiling and reviewing of various GMP-related procedures, protocols and reports.
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Updating or elaboration of Specifications and Test Methods
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Verification of internal and external equipment qualifications.
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Participating in client and regulatory audits, as well as carrying out internal audits.
CANDIDATE PROFILE
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In possession of a scientific degree or diploma.
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Proficient in English and ideally Italian.
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Proficient in the use of Microsoft Office (Word, Excel).
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Knowledgeable in conducting quality investigations, root cause analysis and quality risk assessments.
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Experienced with the pharmaceutical industry and familiar with Good Manufacturing Processes and FDA quality metrics.
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Experienced in a similar role.
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Diligent, self- motivated and with good attention to detail.
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Capable of following standard operational procedures.
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Able to effectively communicate and collaborate with all team members.
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Analytical, meticulous and able to solve problems.
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Able to handle pressure and shifting priorities and remain focused when problems arise.
COMPANY BENEFITS
Due to the high volume of applications we receive at GRS Recruitment, only shortlisted candidates will be responded to.