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.