👋 Quality Assurance Specialist - Onsite (Palmela, Portugal) | English
This is your chance to join a global leader in pharmaceutical development and manufacturing!
Hovione is a family-owned company with a strong commitment to innovation and excellence. We're looking for a passionate and experienced Quality Assurance Specialist to join our team in Palmela, Portugal.
About Hovione:
- We're an independent, international group of companies dedicated to helping pharmaceutical customers bring new and off-patent drugs to market.
- We have over 1950 team members from 36 different nationalities, working across Asia, Europe, and North America.
- We have 4 production sites, including in Portugal, the US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland.
- We're committed to creating a diverse and inclusive workplace where everyone feels supported and respected.
What You'll Do:
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Ensure cGMP compliance: You'll be responsible for guaranteeing cGMP compliance in all activities and systems related to projects and products.
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Streamline processes: You'll ensure working practices are efficient and aligned with the needs of each project.
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Improve quality: You'll implement policies and procedures to continually improve the quality of products and operations.
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Supplier qualification: You'll provide global supplier qualification services for new and existing products.
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Collaborate with suppliers: You'll work with suppliers and Procurement to ensure the quality of their products, materials, components, and operations.
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Manage projects: You'll rigorously manage all quality activities for assigned projects and products, ensuring the site is always audit-ready.
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Promote continuous improvement: You'll be a champion for high-quality levels and a continuous improvement culture.
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Act as a catalyst for change: You'll drive positive change and improvement in performance and quality.
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Support new colleagues: You'll provide professional support and training to new team members.
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Ensure compliance: You'll ensure all project and product activities are delivered in compliance with cGMP requirements and the company's Quality Management System.
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Manage quality activities: You'll manage and participate in key quality activities for assigned products and projects, including preparation, review, and approval of documentation, protocols, and quality-related reports.
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Support audits: You'll prepare for and support internal and external site audits and inspections.
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Ensure inspection readiness: You'll ensure all work completed is inspection-ready and provide advisory support for all internal and external site audits.
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Follow up on deviations and PdAs: You'll track ongoing deviations and PdAs to ensure timely closure of deviations and approval of PdAs.
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Maintain SOPs and IOPs: You'll keep SOPs and IOPs up to date, compliant, and supportive of efficient production.
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Review regulatory documentation: You'll review regulatory documentation and coordinate site documentation to support regulatory requirements.
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Facilitate communication: You'll ensure the effective flow of information between stakeholders, representing the team as appropriate.
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Promote HSE compliance: You'll promote compliance with Health, Safety, and Environment standards.
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Utilize information systems: You'll accurately use and maintain all information systems.
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Generate KPIs: You'll support the generation and reporting of KPIs for the team.
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Develop QA expertise: You'll develop and share your QA expertise with the team, including knowledge of new developments and methodologies.
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Investigate customer complaints: You'll coordinate and assist with the analysis and investigation of customer complaints, ensuring all complaints are investigated and closed out within specified timeframes.
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Provide training: You'll provide training to new colleagues and other areas on cGMP, internal procedures, and quality systems.
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Advocate for safety and quality: You'll be an advocate for safe operating practices and high-quality performance, alerting colleagues to any potential risks, discrepancies, deviations, or non-conformances.
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Ensure timely delivery: You'll ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably, and in a cost-effective manner.
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Propose improvements: You'll propose improvements to the area and solve problems.
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Make informed decisions: You'll make quality and timely decisions within your area of responsibility.
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Gather data for decision-making: You'll gather relevant data to inform decision-makers about complex issues.
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Execute professional activities: You'll execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements, and promote the implementation and maintenance of Hovione's policies, systems, and procedures.
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Work safely: You'll carry out assigned tasks and duties safely, in accordance with instructions, and comply with environmental, health, and safety rules, procedures, regulations, and codes of practice.
What We're Looking For:
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University degree: You'll have a university degree or equivalent in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar scientific field.
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Relevant experience: You'll have 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry.
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GMP experience: You'll have experience working in a GMP operational environment.
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GMP training: You'll have training and experience in GMP standards.
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Regulatory experience: Experience working with Regulatory Affairs and a basic knowledge of the function is desirable.
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Strong GMP understanding: You'll have a strong understanding and knowledge of GMP practices.
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English fluency: You'll be fluent in English.
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Computer literacy: You'll be computer literate with a good working knowledge of the MS Office package.
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Documentation skills: You'll have strong documentation skills and attention to detail.
Ready to make a difference?
We're looking for someone who is passionate about quality and committed to continuous improvement. If you're ready to join a dynamic team and contribute to the success of a global leader in the pharmaceutical industry, we encourage you to apply!
Join us and be part of something bigger. We're In it for life!
Apply now!
Job Category: Healthcare