Junior Quality Assurance

Junior Quality Assurance (Pharma)
Develop your Quality Assurance career within a global pharmaceutical environment, supporting deviations, change controls and GMP compliance in sterile manufacturing operations.
Junior Quality Assurance (Pharma)
Job description:
Support Quality Assurance activities related to sterile manufacturing and filling operations.
Assist with the preparation, assessment and follow\-up of change controls.
Support deviation investigations and ensure that the related documentation is complete and accurate.
Follow up on actions arising from deviations, change controls and other quality records.
Review manufacturing and quality documentation for completeness, consistency and GMP compliance.
Clarify incomplete or unclear documentation with internal stakeholders and the external manufacturing partner.
Monitor open quality records and support their timely progression and closure.
Maintain an overview of several ongoing quality topics and communicate outstanding actions.
Support the evaluation of quality issues within their practical manufacturing context.
Assist with batch record reviews following the initial onboarding period.
Collaborate with colleagues across the global Quality Assurance organisation.
About the customer:
Our client is a global, research\-driven pharmaceutical and biotechnology company developing innovative treatments for complex and serious diseases. To strengthen its international Quality Assurance team, the company is looking for a Junior Quality Assurance Specialist to support quality activities connected to an external sterile manufacturing partner.
This position offers hands\-on exposure to sterile manufacturing, biologics and third\-party production within an international and highly regulated environment. It is well suited to an early\-career QA professional who has gained practical manufacturing experience and would like to further develop within operational Quality Assurance.
Requirements:
Bachelor’s degree or equivalent qualification in Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Engineering or a related field; relevant practical GMP experience may compensate for a different educational background.
2–5 years of experience in Quality Assurance or manufacturing operations within the pharmaceutical, biotechnology or sterile\-production industry.
Hands\-on experience in a GMP\-regulated sterile manufacturing or sterile filling environment.
Practical experience with deviations and change controls.
Fluent English; Italian language skills would be a strong advantage.
Experience working with an external manufacturer, CMO or CDMO would be advantageous.
Knowledge of TrackWise, Veeva or another electronic quality management system would be beneficial.
Experience with batch record review, biologics or antibody\-drug conjugates would be an advantage. jpide0d46c0jm jit0729jm jiy26jm