Quality Director
About the role
Plan, manage and coordinate the development, implementation and maintenance of quality assurance systems.
Ensure compliance of company operations to quality principles and cGMP requirements.
Develop & implement appropriate corrective and preventive action plans to prevent or correct deficiencies.
Develop and implement quality systems including drafting/implementing SOPs and managing training of scientific & production teams on laboratory, QC and analytical procedures.
Act as subject matter lead in FDA inspections, audits and other Quality Assurance tasks.
Review and approve qualification and validation protocols and plans for clean-rooms, systems, and process activities associated with the manufacturing of sterile products in aseptic environments.
Responsibilities
- Plan, manage and coordinate the development, implementation and maintenance of quality assurance systems.
- Ensure compliance of company operations to quality principles and cGMP requirements.
- Develop & implement appropriate corrective and preventive action plans to prevent or correct deficiencies.
- Develop and implement quality systems including drafting/implementing SOPs and managing training of scientific & production teams on laboratory, QC and analytical procedures.
- Act as subject matter lead in FDA inspections, audits and other Quality Assurance tasks.
- Review and approve qualification and validation protocols and plans for clean-rooms, systems, and process activities associated with the manufacturing of sterile products in aseptic environments.
Requirements
- Bachelor’s degree in Chemistry or Pharmaceutical Sciences is required.
- Plus five years’ work experience as Quality Control Manager or Related Occupation is required.