We are currently looking for a Quality Assurance Specialist join our client’s team. QA Specialist who will be responsible for ensuring that all the company processes are in compliance with cGMP practices. This position is on a full-time basis and on day shift.
About our client
Our client is a pharmaceutical company specializing in the development, optimization and manufacturing of high quality generic Active Pharmaceutical Ingredients (APIs), and enhance people’s lives by developing innovative solutions to enable new treatment routes for critical diseases.
Duties and Responsibilities
– 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.
– Managing and participating in training activities
Skills and Requirements
– In possession of a scientific degree or diploma.
– Proficient in English and ideally Italian.
– Proficient in the use of Microsoft Office (Word, Excel).
– Knowledgeable in conducting quality investigations, root cause analysis and quality risk assessments.
– Experienced with the pharmaceutical industry and familiar with Good Manufacturing Processes and FDA quality metrics.
– Diligent, self- motivated and with good attention to detail.
– Capable of following standard operational procedures.
– Able to effectively communicate and collaborate with all team members.
– Analytical, meticulous and able to solve problems.
– Able to handle pressure and shifting priorities and remain focused when problems arise.
Salary and Benefits
– Salary bracket €26, 000 to 40 k depending on experience and qualifications
– Performance Bonus.
– Medical check-ups.
– A welcoming and inclusive environment.
– A state-of-the-art working facility.
– A culture where teamwork is priority.
– A meaningful job where all employees contribute towards improving people’s lives.
– A challenging role with an innovative company.
– Company transport (only from Birzebbuga).
If you meet the requirements and feel that this position is a fit for you, do not hesitate and apply for this role today!