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.