Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
* Rigorously, accurately, efficiently and professionally manage 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"
* Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities
* Act as a catalyst for change and improvement in performance/quality
* Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR
* Provide an example of professionalism and support the induction and training of new colleagues within the area
Qualifications:
* University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)
* Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable)
* Experience of working in a GMP operational environment (mandatory)
* Training and experience of GMP standards (mandatory)
* Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable)
* Strong understanding and knowledge of GMP practices
* Fluency in English is a requirement
* Computer literate with good working knowledge of the MS Office package
* Strong documentation skills and attention to detail
Hovione is a proud Equal Opportunity Employer
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.