Baxter International
l'Alleud, Belgium
Description
Summary (optional)
- Manage and provide Quality support for the successful completion of new and improved (LCM) product design and implementation projects within boundaries of quality, time and budget;
- Provide Subject Matter Expertise (SME) for quality for products specifications (e.g. analytical methods, acceptance criteria, stability indicating test methods);
- Provide expertise on Risk management and design/Development deliverables to multifunctional teams;
- QA support for container and solution product life cycle management activities.
Essential Duties and Responsibilities
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
- Lead and approve CAPA projects and participate in CAPA review process;
- Function as Quality Core Team member supporting new and improved (LCM) product design and implementation projects and manage a variety of complex issues in associated projects;
- Utilize quality tools to solve straightforward problems (e.g. FMEA, fish bone);
- Provide Subject Matter Expertise (SME) for quality for products specifications (e.g. analytical methods, acceptance criteria, stability indicating test methods);
- Provide Guidance on creation and maintenance product Design History Files and Risk Management Files according to relevant Quality System and other regulatory requirements. Provide guidance to the R&D development group on best practices in risk management and development process deliverables.
Qualifications
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
- cGMP, QC & Analytic, Quality Assurance;
- Statistical skill.
Education and/or Experience
Include the education and/or experience that is necessary to perform the job satisfactorily.
- Chemist, Engineer, or Pharmacist.
Experience:
- At least 8 years in a GMP environment (Drug Substances or Drug Products) –Manufacturing, Quality, and/or R&D;
- Experience in international management is a most;
- Good English language skills, orally and in writing.