Senior Quality Assurance Specialist

Quality Assurance Professional

We are seeking a highly motivated and detail-oriented Quality Assurance Professional to join our team. This is an excellent opportunity for someone who wants to make a real difference in the quality of products and processes.

In this role, you will be responsible for ensuring that all activities and systems related to Projects and Products execution comply with Good Manufacturing Practices (GMP). You will also be responsible for implementing policies, procedures, and methods to evaluate and continuously improve the quality of products and operations throughout their lifecycle.

As a Quality Assurance Professional, you will provide global supplier qualification services in support of new product introduction and existing products. You will collaborate 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 assigned projects and/or products in accordance with applicable GMP, quality operational standards/procedures, and legal regulations, ensuring the site is always 'audit ready'.
- Promote 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.
- Provide an example of professionalism.
- Assigned projects may relate to any of the following areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification, Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer Requirements, PQR.
- Efficiently, accurately, and reliably ensure that project and/or product activities are delivered in compliance with GMP requirements and maintenance of the company Quality Management System is assured.
- Manage and participate in Quality Product key activities for assigned product/projects, and introduction of new products; including preparation, review, and approval of auxiliary documentation, protocols, and quality-related reports.
- Prepare for and support internal and external site audits and inspections, conducting regular reviews, and periodically following up action plans as necessary.
- Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits.
- Periodic follow-up of ongoing deviations and Change Controls (PdAs) to assure timely closure of deviations and approval of PdAs, as appropriate.
- Prepares SOPs, department IOPs, quality-related reports, and change control documents (PdAs) as required and appropriate.
- Review process master documentation, revision of executed batch documentation, and product specifications as required and appropriate.
- Ensures that SOPs and IOPs are up-to-date, compliant, and supports efficient production.
- Review regulatory documentation and coordination of site documentation to support regulatory requirements.
- Authorize the usage of production equipment/utilities when qualification required.
- Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required.
- Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate.
- To assure and promote compliance on Health, Safety, and Environment in the area and activities for which is responsible, or in which participates.
- To maintain a regular presence on the manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas, and performing a general oversight of activities, as required.
- Accurately use and maintain all information systems.
- Support the generation/reporting of KPIs for the team.
- Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area.
- Coordinate and assist with the analysis/investigation of customer complaints that may arise, ensuring all complaints are investigated and closed out within specified timeframes.
- Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations, or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements, including those that have the potential to mitigate unnecessary complexity.
- Apply and develop knowledge of Quality Assurance and participate in area processes, procedures, and projects with the guidance of more senior colleagues.
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably, and in a cost-effective manner.
- Execute professional activities in compliance with GMP and HSE guidelines, internal, and external requirements, as well as promote the implementation and maintenance of Hovione's policies, systems, and procedures (COPs, HBR, SOPs, and others).
- Undertake any additional tasks commensurate with the role as and when required.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations, and codes of practice.

---