Vaccine Quality Assurance Section Head
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What you'll do
- Lead QA activities within Sterile Production Operations, ensuring full compliance with sterile manufacturing best practices and regulatory requirements.
- Manage and maintain a robust Quality Management System, integrating ISO standards related to Quality, Environment, and Health & Safety.
- Own and oversee key QA processes, including Change Control, Deviations, Product Recalls and Mock Recalls, Annual Product Quality Reviews, and Customer Complaint management.
- Drive continuous improvement through digitalization initiatives and the application of modern QA tools and statistical approaches such as Minitab.
- Act as the main QA point of contact with Regulatory Affairs, Export, Supply Chain, R&D, and Laboratory teams to ensure effective cross-functional collaboration.
- Support performance management by aligning departmental activities with company KPIs and annual objectives, with preference given to experience in biotechnology and vaccine manufacturing.
What they're looking for
- Bachelor's degree in Pharmacy.
- 8 years+ of proven experience in sterile manufacturing environments.
- Strong knowledge of ISO standards and pharmaceutical GMP requirements, including EU, WHO, and EDA regulations.
- Demonstrated ability to lead teams, manage complex negotiations, and apply constructive problem-solving to operational bottlenecks.
- Excellent interpersonal and communication skills with the ability to engage effectively across diverse technical and commercial stakeholders.
- A proactive and innovative mindset, with a proven track record in system optimization.
Nice to have
- Preference given to experience in biotechnology and vaccine manufacturing.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary:
We are seeking a passionate and talented Vaccine Quality Assurance Section Head to join our dynamic team.
The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
Key Responsibilities:
- Lead QA activities within Sterile Production Operations, ensuring full compliance with sterile manufacturing best practices and regulatory requirements.
- Manage and maintain a robust Quality Management System, integrating ISO standards related to Quality, Environment, and Health & Safety.
- Own and oversee key QA processes, including Change Control, Deviations, Product Recalls and Mock Recalls, Annual Product Quality Reviews, and Customer Complaint management.
- Drive continuous improvement through digitalization initiatives and the application of modern QA tools and statistical approaches such as Minitab.
- Act as the main QA point of contact with Regulatory Affairs, Export, Supply Chain, R&D, and Laboratory teams to ensure effective cross-functional collaboration.
- Support performance management by aligning departmental activities with company KPIs and annual objectives, with preference given to experience in biotechnology and vaccine manufacturing.
Requirements
- Bachelor's degree in Pharmacy.
- 8 years+ of proven experience in sterile manufacturing environments.
- Strong knowledge of ISO standards and pharmaceutical GMP requirements, including EU, WHO, and EDA regulations.
- Demonstrated ability to lead teams, manage complex negotiations, and apply constructive problem-solving to operational bottlenecks.
- Excellent interpersonal and communication skills with the ability to engage effectively across diverse technical and commercial stakeholders.
- A proactive and innovative mindset, with a proven track record in system optimization.
Company
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