Job Overview
Hovione, an independent family-owned international group of companies, is seeking a highly skilled Quality Assurance professional to join our team. As a leader in Contract Development and Manufacturing, we help pharmaceutical customers bring new and off-patent drugs to market.
We pride ourselves on innovation and excellence, with over 1950 team members from 36 nationalities across Asia, Europe, and North America. Our four production sites are hubs for collaboration and continuous improvement.
This role offers the opportunity to contribute to the success of our company, working closely with clients, partners, and patients. Your dedication will make a meaningful impact on their lives.
Key Responsibilities:
* Ensure compliance with cGMP standards in all project-related activities and systems.
* Simplify and align working practices with each project's specific needs.
* Implement policies, procedures, and methods to evaluate and improve product quality and operations throughout the lifecycle.
* Provide global supplier qualification services to support new products and existing ones.
* Collaborate with suppliers and Procurement to ensure the quality of their products and materials.
* Manage quality activities for assigned projects and products in accordance with applicable regulations and standards.
* Promote high-quality levels and a continuous improvement culture within the company.
* Foster change and improvement in performance and quality.
* Lead by example, providing training and induction to new colleagues.
* Authorize the release of finished products (applicable to sites without QP).
* Prepare for and support internal and external site audits and inspections.
* Ensure inspection readiness and provide advisory support for audits.
* Close open deviations and propose CAPAs based on follow-up outcomes.
* Develop SOPs, department IOPs, and quality-related reports as required.
* Review regulatory documentation and coordinate site documentation to meet regulatory requirements.
* Maintain effective communication between stakeholders.
* Promote Health, Safety, and Environment compliance in your area and activities.
* Be present on the manufacturing floor, providing on-the-job support.
* Develop and sign-off training materials.
* Manage complex projects/analysis with significant business impact.
* Perform professional activities in compliance with GMP and HSE guidelines.
Requirements:
* University or equivalent qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar scientific field.
* Typically requires 5-8 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry.
* Experience working in a GMP operational environment.
* Training and experience with GMP standards.
* Knowledge of Regulatory Affairs and a well-rounded understanding of the function.
* Fluency in English is mandatory.
* Computer literacy with a good working knowledge of the MS Office package.
* Advanced documentation skills and attention to detail.
Hovione is an equal opportunities employer.
Inclusion and diversity are essential to us. At Hovione, we value differences and treat everyone with fairness and respect.