Manufacturing Process Evaluation Specialist

Grifols, S.A; Parets del Vallès; Híbrido; EUR 45.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Occasionally remote

Descripción de la vacante

Grifols, S.A is seeking a Manufacturing Process Evaluation Specialist within the Product Quality area of the Quality Assurance division to support robust process control and compliant documentation.

You will analyze incidents, coordinate corrective actions, review qualification/validation documentation, and prepare audit-ready reports for national and international bodies.

A Health Sciences degree with GMP knowledge and advanced English is required, with at least two years in quality roles.

Formación

• Minimum education in Health Sciences (Pharmacy, Biology, Chemistry); Master or postgraduate in pharma is a plus.
• Knowledge of GMP (Good Manufacturing Practice).
• Knowledge of Basic Statistics.
• Advanced level of English.

Responsabilidades

• Control and document incidents arising in production and control processes.
• Supervise follow-up of corrective or preventive actions from incidents.
• Analyze data and trends from processes.
• Prepare system review reports based on collected/analyzed data.
• Coordinate follow-up groups to communicate process evaluations and trends.
• Review documentation describing production operations and equipment/facilities.
• Review qualification and validation protocols and reports.
• Prepare and deliver documentation requested during audits/inspections by national and international bodies.

Conocimientos

GMP knowledge

Basic statistics

MS Office

SAP

Advanced English

Educación

Health Sciences Degree (Pharmacy, Biology, Chemistry)

Master or Postgraduate degree in pharmaceutical sector

Descripción del empleo

Manufacturing Process Evaluation Specialist

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.

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.

We are looking for Manufacturing Process Evaluation Specialist within the Product Quality area of the Quality Assurance division of Instituto Grifols SA, a company specialized in the research, development and production of purified plasma proteins with therapeutic properties obtained from the fractionation of human plasma.

What your responsibilities will be

• You will control and document incidents arising in production and control processes.
• You will supervise the follow-up of corrective or preventive actions derived from incidents in production and control processes.
• You will analyze data and trends from the processes.
• You will prepare system review reports based on the collected and analyzed data.
• You will coordinate follow-up groups to communicate process evaluations and trends.
• You will review documentation that describes production operations and the functioning of equipment and facilities.
• You will review qualification and validation protocols and reports.
• You will prepare and deliver the documentation requested during audits and inspections conducted by national and international organizations and other companies.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

• You have a minimum education in Health Sciences Degree (Pharmacy, Biology, Chemistry), being valuable to have a Master or Postgraduate degree in the pharmaceutical sector.
• You have knowledge in GMP.
• You have knowledge in Basic Statistics.
• You have knowledge of MS Office and SAP program.
• You have advanced level of English.
• You have at least 2 years of experience in similar position within Quality.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Flexibility for U Program:

Occasionally remote

Schedule:

Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).

Contract of Employment:

Permanent position

SAP / Grifols