Quality Assurance Associate

Há 1 mês

Lisboa, Portugal Hovione Tempo inteiro

Join a Market Leader:
Hovione is an independent family-owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

You will be responsible for:

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 to continuously improve the quality of products and operations throughout the products 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.

Rigorously, accurately, efficiently and professionally 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.

Ensuring that project and/or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured.

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.

Preparing for and supporting internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary.

Ensuring inspection readiness in work completed and acting 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.

Preparing SOPs, department IOPs, quality related reports and change control documents (PdAs) as required and appropriate.

Reviewing process master documentation, revision of executed batch documentation and product specifications as required and appropriate.

Ensuring that SOPs and IOPs are up to date, compliant and supports efficient production.

Reviewing regulatory documentation and co-ordination of site documentation to support regulatory requirements.

Authorizing the usage of production equipment/utilities when qualification required.

Solving challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required.

Ensuring the effective and proactive flow of information between stakeholders, representing the team as appropriate.

Promoting compliance on Health, Safety and Environment in the area and activities for which responsible.

Maintaining a regular presence on 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 using and maintaining all information systems.

Supporting the generation/reporting of KPIs for the team.

Developing and accumulating strong QA expertise, sharing knowledge of new developments and methodologies within the area.

Coordinating and assisting with the analysis and investigation of customer complaints that may arise, ensuring all complaints are investigated and closed out within specified timeframes.

Being 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.

Applying and developing knowledge of Quality Assurance and participating in area processes, procedures and projects with the guidance of more senior colleagues.

Performing to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner.

Executing professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promoting the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).

Undertaking any additional tasks commensurate with the role as and when required.

Carrying 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.

We are looking to recruit a Candidate:

University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory).

Requires educational/training experience in a QA GMP environment within the Pharmaceutical Industry (desirable).

Experience of working in a GMP operational environment (desirable).

Training and experience of GMP standards (desirable).

Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable).

Knowledge of GMP practices.

Fluency in English is a requirement.

Computer literate with good working knowledge of the MS Office package.

Good 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.

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.

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