👩🔬 About Hovione
Hovione is an independent, family-owned international group of companies that's a leader in the market. They've built a strong reputation through innovative technologies and production capabilities, becoming a top-tier Contract Development and Manufacturing Company. Hovione helps pharmaceutical companies bring both new and established medications to market.
💪 Our Team
Hovione's team is a key part of their ongoing success. They have over 1950 team members from 36 different countries across Asia, Europe, and North America (including Portugal, the US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), with 4 production sites.
🎯 The Role
You'll be responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) in all project and product-related activities and systems. You'll work to streamline processes and adapt them to each project's unique needs. You'll also implement quality-focused policies, procedures, and methods to continuously improve the quality of products and operations throughout their lifecycle.
What You'll Do
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Maintain cGMP Compliance: Manage all quality activities for assigned projects and products, ensuring alignment with cGMP, quality standards, and regulations. Maintain a constant "audit-ready" state for the site.
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Champion Quality: Promote the importance of high-quality standards and a continuous improvement mindset in relevant company activities. Be a driver for positive change and performance enhancement.
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Project Focus: Work on a range of projects, potentially including raw materials, suppliers, specifications, production processes, change control, deviations, quality agreements, and more.
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Mentorship and Training: Demonstrate professionalism and support the onboarding and training of new colleagues within the Quality Assurance team.
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Ensure Project Delivery: Guarantee projects and/or product activities are delivered in line with cGMP requirements and that the company's Quality Management System is maintained.
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Product Quality Management: Be involved in key quality activities for assigned products/projects and the introduction of new products. This includes tasks like preparing, reviewing, and approving relevant documentation and reports.
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Audits and Inspections: Prepare for and support internal and external site audits and inspections. Conduct regular reviews and follow-up on action plans.
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Deviation Management: Follow up on ongoing deviations and proposed actions to ensure timely closure and approvals.
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Documentation: Prepare Standard Operating Procedures (SOPs), department-specific instructions, quality-related reports, and revise batch documentation and change control documents as needed.
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Approvals: Approve instructions, process master documentation, and product specifications as required.
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SOP Maintenance: Keep SOPs and instructions up-to-date, compliant, and supportive of efficient production.
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Regulatory Support: Review regulatory documentation and coordinate site documentation to fulfill regulatory requirements.
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Equipment Authorization: Authorize the use of production equipment and utilities when qualification is necessary.
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Problem Solving: Provide collaborative and timely support to all areas and departments to address compliance issues, escalating as needed.
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Information Flow: Ensure effective and proactive information sharing between stakeholders, representing the team as appropriate.
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Health, Safety, and Environment (HSE): Promote and uphold compliance with HSE in the assigned area and related activities.
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Manufacturing Floor Presence: Maintain a regular presence on the manufacturing floor, providing support, fostering collaboration with operational areas, and performing oversight as required.
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Validation: Approve Validation Master Plans, Process Validation Protocols, and reports as needed.
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Information Systems: Utilize and maintain all relevant information systems accurately.
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KPI Reporting: Support the generation and reporting of Key Performance Indicators (KPIs) for the team.
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QA Expertise: Develop and maintain strong QA expertise, sharing knowledge of new developments and methodologies within the team.
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Customer Complaint Management: Coordinate and assist with the analysis and investigation of customer complaints, ensuring they're investigated and resolved within the designated timeframe.
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Training and Development: Provide relevant training to new colleagues and other areas on cGMP, internal procedures, and quality systems.
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Risk Management: Advocate for safe operations and high-quality performance, informing supervisors of any potential risks, discrepancies, deviations, or non-conformances.
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Task Delivery: Ensure assigned tasks are planned and delivered on time, safely, efficiently, reliably, and cost-effectively.
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Continuous Improvement: Propose improvements to the area and solve problems.
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Decision Making: Make informed and timely decisions within the scope of Quality Assurance tasks.
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Data Gathering: Gather data to inform decision-makers regarding complex issues.
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Compliance: Execute professional activities in accordance with GMP and HSE guidelines, internal and external requirements. Promote Hovione's policies, systems, and procedures.
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Additional Responsibilities: Undertake any additional tasks related to the role as needed.
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Safety: Carry out assigned tasks and duties safely, following instructions and complying with all environmental, health, and safety rules and regulations.
What We're Looking For
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Education: University degree or equivalent in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific field (required).
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Experience: 3-5 years of relevant experience in a QA GMP environment within the pharmaceutical industry (preferred).
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GMP Environment: Experience working in a GMP operational environment (required).
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GMP Standards: Training and experience in GMP standards (required).
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Regulatory Affairs: Experience working with Regulatory Affairs and a basic understanding of the function (desired).
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GMP Knowledge: A strong understanding and knowledge of GMP practices.
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Language Proficiency: Fluency in English (required).
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Computer Skills: Computer literacy with good working knowledge of the Microsoft Office suite.
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Documentation Skills: Strong documentation skills and attention to detail.
Hovione is an equal opportunity employer.
We believe that inclusion and diversity are essential. At Hovione, we foster a work environment where differences are valued, and everyone is treated with fairness and respect. We aim to support all our team members globally, enabling them to feel respected and reach their full potential, irrespective of age, gender, religion, disability, sexual orientation, or ethnicity.
Job Category: Quality Assurance