Collaborate with site operations and quality control personnel to deliver active pharmaceutical ingredients and pharmaceutical excipients meeting appropriate quality guidance. The quality engineer is accountable for compliance of GMP processes with ICH Q7, IPEC and other applicable quality standards.
Perform product release for GMP manufactured product in accordance with ICH Q7 and/or IPEC requirements.
Disposition off grade and returned GMP manufactured product.
Maintain procedures pertinent to GMP manufacturing.
Design and deliver GMP training to site associates.
Investigate customer complaints, manufacturing deviations, off grade production for GMP manufactured product.
Perform ICH Q7, IPEC internal audits. Work with site personnel to address audit findings.
Perform shop floor inspections to drive compliance to ICH Q7, IPEC and other applicable quality standards.
Lead analytical test method validations from validation protocol drafting to validation completion report approval. Lead or support other validation activities as needed.
Manage raw material supplier audit program. Work with raw material suppliers to address audit findings.
Manage toller audit program. Work with tollers to address audit findings.
Site point of contact for customer and regulatory audits. Work with site personnel to address audit findings.
Support GMP regulatory efforts as needed.
Bachelors of Science, ideally in Chemistry, Chemical or Mechanical Engineering.
10+ years of experience in a GMP ICH Q7 and/or IPEC manufacturing environment, demonstrating increasing levels of responsibility and competence.
Ability to travel ~ 25% of the time.
Knowledge of analytical chemistry, organic chemistry, ICH Q7, IPEC.
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, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Understanding manufacturing processes and value chain.
Understand key operational metrics and communicate across organization to achieve clear alignment and focus.
Understanding of quality systems, ICH Q7 and/or IPEC requirements.
Understanding processes to engage cross-functional teams to solve quality problems.
Able to take verbal directions.
Understand written procedures.
Must be able to read, write and speak English
Complete all required Training:
Department’s reading requirements
Performance and results orientation
Data driven, strong analytical/statistical skill set.
Passion for right first time quality.
Integrity and courage of conviction to maintain quality standards
Employer will assist with relocation costs.
Internal Number: 11965
Solvay is a science company whose technologies bring benefits to many aspects of daily life. Our purpose—we bond people, ideas and elements to reinvent progress—is a call to go beyond, to reinvent future forms of progress and create sustainable shared value for all through the power of science. In a world facing an ever-growing population and quest for resources, we aim to be the driving force triggering the next breakthroughs to enable humanity to advance while protecting the planet we all share.
We bond with customers and partners to address today and tomorrow’s megatrends. As a global leader in Materials, Chemicals and Solutions, Solvay brings advancements in planes, cars, batteries, smart and medical devices, water and air treatment, to solve critical industrial, social and environmental challenges. You can count on our innovative solutions to contribute to safer, cleaner and more sustainable future.