Sr Director, Quality Large Molecule
Thermo Fisher ScientificSalary not specified
- Full Time
- Expert & Leadership (9+ years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical ManufacturingIndustries
Requirements
The ideal candidate is a licensed Industrial Pharmacist (or currently in the process of validation), possessing a Master's degree in Quality Assurance and/or Pharmaceutical Production and/or Pharmaceutical Engineering. They should have a minimum of a Bachelor's degree in a related field and ideally possess a B2 level of English proficiency.
Responsibilities
The CDI Pharmacien Industriel will evaluate the quality of batch assembly and/or finished product dossiers and make decisions regarding the continuation or stoppage of production and/or shipment of finished products based on quality issues. They will manage quality deviations, assess their criticality and impact on products, implement corrective action plans to prevent recurrence, evaluate the quality impact of equipment/process/process modifications, review and approve quality and technical documents and procedures, apply and enforce Good Manufacturing Practices (GMPs), provide quality support to production teams, assist with quality assessment and operator training, support clients internally, lead improvement projects, present QA topics during audits or regulatory inspections, and ensure pharmaceutical coverage for the site.
Skills
GMP
Quality Assurance
Batch Assembly
Finished Product Dossiers
Deviation Management
Corrective Action Plans
Equipment Validation
Process Validation
Quality Documents
Regulatory Inspections
Pharmaceutical Production
Operator Training
Quality Support
Audits
Improvement Projects
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees