University degree in Chemistry, Biochemistry, Biotechnology, Pharmacy, or equivalent degree.
More than 5 years of experience in the pharmaceutical industry (desired areas: Quality and/or Validations).
Essential training or knowledge in validation systems and aseptic technologies.
Experience with Combination Products and their regulations is highly valued.
Fluent spoken and written English and Spanish.
A person with rapid adaptation to change, flexibility, attention to detail, organized, autonomous, and with good communication, pedagogical, and empathy skills.

Flexible schedule
Life and accident insurance
Health insurance at a competitive price
Investment in training and development
Healthcare
Employee job portal
Smartworking

Within the QA Systems Product department, the responsibility is to implement and maintain systems that ensure GMP compliance of products and processes (APQRs, CSV&C, review and approval of documents and master data...).

Functions and Responsibilities:

• Evaluate and approve documents related to the validation lifecycle of manufacturing and packaging processes, equipment cleaning, and transport of aseptic and oral products in accordance with cGMP, FDA regulations, and corporate and local procedures (VMP, VPP, RA, Control Strategy, PPQs, CPV, CTV, cleaning monitoring and their periodic reviews).
• Evaluate and approve documents related to the qualification lifecycle of equipment and computerized systems, facilities, and services in accordance with cGMP, FDA regulations, and corporate and local procedures.
• Ensure GMP and regulatory compliance of procedures associated with manufacturing, equipment cleaning, and transport through the review of documentary content (SOP).
• Design and implement periodic product reports (PQR/APR) for products manufactured at the Sant Cugat plants in accordance with cGMP, FDA regulations, and corporate and local requirements.
• Review and approve documents related to the validation lifecycle of analytical methods and analysis prescriptions.
• Ensure GMP and regulatory compliance of the ERP system content (analysis specifications, standards, manufacturing recipes, and master data).

Profile and Requirements:

• University degree in Chemistry, Biochemistry, Biotechnology, Pharmacy, or equivalent degree.
• More than 5 years of experience in the pharmaceutical industry (desired areas: Quality and/or Validations).
• Essential training or knowledge in validation systems and aseptic technologies.
• Experience with Combination Products and their regulations is highly valued.
• Fluent spoken and written English and Spanish.
• A person with rapid adaptation to change, flexibility, attention to detail, organized, autonomous, and with good communication, pedagogical, and empathy skills.

At Boehringer Ingelheim, we value and appreciate the diversity of talent within our organization. Nevertheless, we find it necessary to inform interested candidates that, for this position, we cannot consider applications involving international relocation.

#IamBoehringerIngelheim because...

We are continuously working because we want to design the best experience for you. These are some examples of how we will take care of you:

• Flexible schedule
• Life and accident insurance
• Health insurance at a competitive price
• Investment in training and development
• Healthcare
• Employee job portal
• Smartworking

If you have read this far, what are you waiting for to apply? We want to know more about you!