Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Position Summary:

The QA Packaging Compliance specialist reports directly to the QA Packaging Compliance Manager of Grifols Worldwide Operations (GWWO).

The successful candidate will be responsible for ensuring that all activities related to non-conformities, complaints, CAPAs, Change controls are performed on a timely manner and in compliance with the company's regulatory requirements.

Strong knowledge and understanding of regulations and guidelines in packaging process and QA inspection activities in packaging.

The successful candidate will have strong technical writing skills, problem solving, and analytical thinking, teamwork, and communication skills capable to delivery to tight and often multiple deadlines in a dynamic, challenging work environment.

Key Responsibilities:

Communication

To provide daily report to QA performance information as required.

To communicate quality metrics information where applicable.

To attend packaging tier meetings and provide information on investigations progress as necessary.

Ensure regular Quality interaction with other departments.

Main activities

• Proficiently lead and actively participate in the investigation of Deviations/non-conformances/technical Complaints to ensure investigations are completed in a timely manner and a high quality under standards.

• Effectively and efficiently write Deviations/Non-conformances, investigations, and reports.

• Effectively reviews and evaluations for completeness and compliance of the investigation reports and CAPA plans authored by Subject Matter Experts (SMEs), and other company personnel.

• Efficiently follow up and verifies that corrective preventive actions are appropriated, are implemented as planned, and have the intended effectiveness in the QA packaging area.

• Participate/Lead investigations due to quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.

• To lead quality risk assessment related to the area

• Responsible for developing and improving SOP’s

• Responsible for periodic reviews and updates of QA packaging SOPs

• Participate and action change controls tasks assigned to the QA packaging department

• Responsible for participating in the internal audit program as deemed necessary

• Lead process/product/system improvement projects in the QA packaging

• Training of the new QA Packaging personnel when required

• GMP implementation and site-wide Quality Awareness related to packaging process

• Participate in various inspections e.g. HPRA, FDA and customers, etc.

• Liaise with other department representatives to promote improvements in GMP and quality standards

• Any additional tasks as assigned by the QA Packaging Compliance Manager, Associate Quality Assurance (QA) Director or Technical Director.

Person Specification

Knowledge & Skills

Essential

• At least 5 years of experience in quality or manufacturing setting or similar role

• Strong technical writing skills

• Competence in Microsoft packages, especially Word, Excel, and PowerPoint, and in SAP

• Ability to handle multiple projects, tasks, and deadlines, proficiency in communicating and collaborating at all levels of the organization

• Demonstrated problem-solving skills and analytical approach

• Demonstrated project management skills

• Strong decision-making skills

• Knowledge of quality risk management tools

• Certification in project management disciplines

• Certification in problem-solving techniques.

Desirable:

• Knowledge of quality risk management tools

• Certification in project management disciplines

• Certification in problem-solving techniques.

Qualifications:

Min. BSc or equivalent in chemistry, biochemistry, pharmaceutical science, or related field

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

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Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Req ID: 527114

Type: Regular Full-Time

Job Category: