Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Lumiar site:
Senior Supplier Quality Assurance (M/F)
The person will be responsible to lead Supplier Quality related activities in support to business objectives and work closely with suppliers to liaise in quality matters, namely documentation for approval and maintenance of supplier qualification programs, issue complaints to suppliers and work with them to obtain an appropriate CAPA plan and an accurate root cause determination and lead supplier development and improvement initiatives.
The Senior Supplier Quality Assurance will also be responsible to plan, schedule and conduct supplier audits and Assist in establishing Quality Agreements with suppliers.
Internally, will be responsible to provide technical support in the selection and qualification of suppliers and service providers; evaluate CAPA reports issued for non –conformities and prepare complaints to suppliers; perform supplier quality metrics monitoring and refine metrics as needed, propose and review supplier quality procedures to ensure compliance with customer and regulatory requirements.
- Assure that suppliers selected understand and comply with Hovione quality requirements;
- Perform supplier review assessments to assure compliance with Hovione requirements including verification of supplier questionnaires, declarations and certifications, audits output, quality agreements, quality review of product/ service provided
and feedback from other team members;Propose suppliers for qualification;
- Participate with internal project teams in investigations and root cause analysis determination to support supplier complaints;
- Issue complaints to suppliers and perform CAPA completions follow-up;
- Track supplier quality performance and report to management and suppliers;
- Improve supplier quality metrics by driving improvement plans with suppliers;
- Analyze and identify trends from quality data and develop proactive measures with supplier in support of continuous improvement;
- Perform supplier development activities with suppliers identified, including supplier quality plans, conducting for- cause audits, supplier corrective action follow-up and implementing continuous improvement methods and techniques;
- Perform supplier audits and manage audit closures with suppliers;
- Develop and review supplier Quality Agreements (in collaboration with other team members) and establish a process to assure that key quality expectations are reflected in suppliers operations and updates for changes are managed;
- Propose, maintain and review supplier quality procedures to ensure compliance with customer and regulatory requirements;
- Serve as subject matter expert in problem solving methodologies/ root cause analysis and provide training when required.
- Master Degree in Engineering or Life Sciences
- Background in quality assurance and thorough understanding of quality tools and techniques;
- Experience in supplier auditing, supplier qualification and in writing, evaluation and closing investigations;
- Good English written and verbal communication skills;
- Good communication and interpersonal relationship skills;
- Good organization, precision and responsibility, assertiveness and self-confidence;
- Autonomous, dynamic, flexible and capable to work under pressure in simultaneous projects;
- Ability to see beyond the obvious;
- Organized, accurate and responsible.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.