Hovione is a market leader in the contract development and manufacturing of pharmaceutical products. Our innovative technological capabilities have earned us a top spot in the world market as an integrated company dedicated to helping customers bring new and off-patent drugs to market.
About Us
We are a family-owned international group of companies with over 1950 team members from 36 different nationalities, located across Asia, Europe, and North America. Our people are our main asset for continued success.
Our Mission
We strive for innovation and excellence in everything we do: for our clients, partners, and above all, patients. That's why we're In it for life.
Job Description
The successful candidate will be responsible for ensuring cGMP compliance in all activities and systems related to projects and product execution. This includes:
* Guaranteeing cGMP compliance in all activities and systems related to Projects and Products execution;
* Assuring that working practices are streamlined and aligned with the actual needs of each project;
* Implementing policies, procedures, and methods to evaluate and continuously improve the quality of products and operations throughout the product lifecycle;
* Providing global supplier qualification services in support of new product introduction and existing products;
* Collaborating with suppliers and Procurement to assure the quality of their products, materials, components, and/or operations;
* Managing all quality activities for the assigned projects and/or products in accordance with applicable cGMP, quality operational standards/procedures, and legal regulations, ensuring the site is always 'audit ready';
* Promoting the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities;
* Acting as a catalyst for change and improvement in performance/quality;
* Providing an example of professionalism and leading the induction and training of new colleagues within the area;
* Managing and participating in Quality Product key activities for the assigned product/projects, including preparation, review, and approval of auxiliary documentation, protocols, and quality-related reports;
* Authorizing the release for sale of finished products (applicable to site without QP);
* Preparing for and supporting internal and external site audits and inspections;
* Ensuring inspection readiness in work completed and acting in an advisory capacity for all internal and external site audits;
* Closing open deviations and proposing CAPAs based on the outcome of periodic follow-ups;
* Preparing SOPs, department IOPs, quality-related reports, revision of executed batch documentation, and change control documents (PdAs) as required;
* Reviewing regulatory documentation and coordinating site documentation to support regulatory requirements;
* Ensuring the effective and proactive flow of information between stakeholders;
* Promoting compliance on Health, Safety, and Environment in the area and activities for which you are responsible;
* Maintaining a regular presence on the manufacturing floor, providing on-the-job support;
* Leading the development and sign-off of training materials;
* Managing complex projects/analysis with significant impact on business;
* Executing professional activities in compliance with GMP and HSE guidelines;
* Undertaking any additional tasks commensurate with the role as required.
Requirements
The ideal candidate will have:
* A University or equivalent qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar scientific field (mandatory);
* Typically requires 5-8 years of relevant experience within a QA GMP environment within the Pharmaceutical Industry (mandatory);
* Experience of working in a GMP operational environment (mandatory);
* Training and experience of GMP standards (mandatory);
* Experience of working with Regulatory Affairs and a well-rounded knowledge of the function (mandatory);
* Fluency in English is a requirement;
* Computer literate with good working knowledge of the MS Office package;
* Advanced documentation skills and attention to detail;
* Must have the Knowledge, Experience, and Skills to conduct their tasks in accordance with the rules and procedures set down.
About Hovione
Hovione is a proud Equal Opportunity Employer. We value inclusion and diversity, promoting a work environment where differences are valued, and everyone is treated with fairness and respect.