Quality Assurance Specialist Lazio

Quality Assurance Specialist
Roma
Lazio, Lazio

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We are looking for a highly motivated Quality Assurance Specialist for our warehouse site in Anagni (FR). Your RoleThe Quality Assurance Specialist supports the Contract Logistics Quality Manager for Healthcare products, focusing on the implementation and maintenance of quality processes within our contract logistics operations.

The role involves ensuring compliance with industry standards and European regulatory requirements, managing product inspections, and contributing to continuous improvement initiatives. Your ResponsibilitiesSupport the implementation and maintenance of a quality management system compliant with current site authorizations and national legislation requirements for certain products. Aid in the preparation of documentation for AIFA (Italian Medicines Agency) and other regulatory bodies for new applications. Assist in the management of psychotropic drugs according to D. P. R.

309/90 and its amendments, ensuring the availability of Import/Export permits and timely notifications to the Ministry of Health. Manage the process for returned, rejected, recalled, or falsified products. Address customer complaints efficiently to ensure satisfactory resolutions. Support the qualification of suppliers, systems, and equipment. Assist in managing training and audit programs to ensure staff compliance with current standards. Support the identification, investigation, and reporting of compliance issues, irregularities, and violations. Aid in the implementation and management of CAPA (Corrective and Preventive Actions) plansEnsure temperature monitoring of warehouse and critical systems comply with GXP standards. Your Skills and ExperiencesBachelor's degree in Pharmaceutical chemistry, Pharmacy, Chemistry, Industrial Chemistry, Biological Sciences. 3 years of experience in pharmaceutical production or a similar role. Eligibility to be certified as a Qualified Person. Strong knowledge of GMP and regulatory requirements. Excellent problem-solving and analytical skills. Ability to work effectively in a team environment. Strong communication and interpersonal skills. Proficiency in English and Italian.

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