The Role
The Quality Engineer will provide quality oversight to manufacturing and technical activities, ensuring compliance with
GMP, regulatory, and internal quality standards
, while supporting site projects and NPI activities.
Key Responsibilities
* Provide quality engineering support to
manufacturing, validation, and technical teams
* Act as Quality representative for
New Product Introduction (NPI)
projects, supporting tech transfer and process scale-up
* Support preparation, review, and approval of
GMP documentation
(SOPs, protocols, reports)
* Lead and support
deviations, CAPAs, change controls, and risk assessments
* Support
process validation, cleaning validation, and equipment qualification
activities
* Participate in internal, customer, and regulatory audits and inspections
* Drive continuous improvement initiatives to enhance product quality and compliance
* Ensure quality systems align with
ICH, EU GMP, and FDA requirements
Requirements
* Degree in
Engineering, Science, or a related discipline
* Experience in a
Quality Engineering or Quality Assurance role
within the pharmaceutical or biotech industry
* Strong working knowledge of
GMP and quality systems
* Experience supporting
NPI, tech transfer, or process introduction
is highly desirable
* Familiarity with deviation management, CAPA, and change management systems
* Strong problem-solving, communication, and stakeholder management skills
Desirable
* Experience with
sterile manufacturing, biologics, or fill-finish operations
* Knowledge of
risk management tools
(FMEA, Fishbone, 5 Whys)
* Experience working with cross-functional project teams