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 Validation Lead is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in GWWO.

Technical expertise in biopharmaceutical manufacturing is required to provide support to Commercial and Clinical manufacturing operations as well as Process Development operations.

This position requires a detailed knowledge and understanding of product-contacting materials, technologies, applications, and suppliers. This position can also require knowledge of industry standards that govern chemical raw materials (USP, compendia, etc.);.knowledge and understanding of Annex 1 and aseptic regulatory requirements is essential.

KEY RESPONSIBILITIES :

• Act as a representative for the Quality team in the absence of the quality supervisor/manager

• Communication:

• Provide material and supplier qualification information as required

• Ensure regular Quality interaction with other Departments

• Quality Assurance Activities:

• Designing and developing policies for validation and ensuring that they are effectively administered and comply with regulatory requirements

• Leading all aspects of QA validation including reviewing and approving of the following types of documents, relating to area functions: Failure investigations, Change controls and associated Test Plan documentation, SOPs, Validation protocols and summary reports, Validation Master Plans

• Managing QA Validation Department personnel by assisting in developing validation work plans, establishing objectives, and assigning tasks

• Developing and managing QA validation budget, contracts, and schedules

• Presenting and defending data to HPRA, FDA and other regulatory agencies

• Maintaining QA validation document and software control system

• Ensuring efficient working alongside the Validation department to ensure validation status is maintained for equipment and software use in commercial and clinical manufacturing

• Organizing QA validation resource assigned to functional area to meet goals and timings; coordinating and prioritizing of activities with area management

• Playing a proactive role in developing and applying new approaches and processes to validation strategies

• Working with senior managers and executives to support and assist in developing a broad-based validation program.

• Appling complete functional knowledge and awareness of company goals and objectives

• Supporting employees work performance; conducts hiring and discharge interviews.

• Create projects, spreadsheets, and presentations via Microsoft Office programs.

• Continued education on understanding of new technologies and regulations.

PERSON SPECIFICATION:

• Excellent communication skills

• Strong technical writing skills.

• Competence in Microsoft packages specifically word, excel and PowerPoint

• Good organizational skills

• Flexibility

• Results orientated

• Ability to make decisions

• Ability to handle multiple projects and deadlines.

• Deep knowledge and understanding of the aseptic regulatory requirements

• Minimum of B.Sc Degree in Life Sciences, Chemistry or Engineering with at least 5 years’ experience in a quality or production function within the biological/ aseptic pharmaceutical/.

• Technical expertise in biopharmaceutical manufacturing.

• Direct people management.

• Experience in a project/start up environment.

Our Benefits Include:

• Highly competitive salary

• Group pension scheme -Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match

• Private Medical Insurance for the employee

• Ongoing opportunities for career development in a rapidly expanding work environment

• Succession planning and internal promotions

• Education allowance

• Wellness activities - Social activities eg. Padel, Summer Events

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

#LI-FD1

Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3

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

Req ID: 526379

Type: Regular Full-Time

Job Category: