Quality Management System (QMS):
- Develop, implement, and maintain an effective Quality Management System (QMS) in compliance with regulatory requirements.
- Continuously assess and improve the QMS to enhance efficiency and effectiveness.
Regulatory Compliance:
- Stay abreast of relevant regulatory requirements and ensure the plant's compliance with local and international quality standards.
- Interface with regulatory authorities as needed for inspections and approvals.
Quality Assurance:
- Establish and maintain quality policies and procedures.
- Conduct internal audits to ensure adherence to established quality standards.
- Oversee the documentation and review of batch records, specifications, and other relevant documents.
Quality Control:
- Develop and implement robust quality control processes for incoming raw materials, in-process production, and finished products.
- Supervise the testing and inspection of materials and products to ensure compliance with specifications.
aboration:
- Collaborate with cross-functional teams, including production, R&D, and supply chain, to drive quality improvements throughout the product life cycle.
Quality Metrics:
- Develop and report key performance indicators (KPIs) related to quality, providing regular updates to senior management.
Qualifications:
- Bachelor's or Master's degree in a relevant scientific or engineering discipline.
- 8+ years of experience in quality assurance and quality control within the empty capsules, or related industry.