Responsibilities:
- Quality System Oversight:
- Develop, implement, and maintain a comprehensive quality management system for the bio-organic manufacturing unit.
- Ensure compliance with relevant quality standards, regulations, and industry best practices.
- Quality Audits:
- Conduct regular internal audits to assess adherence to quality processes and standards.
- Collaborate with external auditors and regulatory agencies as needed.
- Batch Quality Control:
- Establish and enforce stringent quality control measures for each stage of the batch production process.
- Conduct thorough inspections and checks to ensure product consistency and adherence to specifications.
- Documentation Management:
- Oversee the creation, maintenance, and review of all quality-related documentation, including Standard Operating Procedures (SOPs) and batch records.
- Implement document control procedures to ensure accuracy and accessibility.
- Quality Training:
- Provide training to production staff on quality standards, procedures, and the importance of compliance.
- Ensure ongoing awareness of quality requirements throughout the organization.
- Non-Conformance Management:
- Develop and implement procedures for identifying, documenting, and addressing non-conformances.
- Lead investigations into quality incidents, determine root causes, and implement corrective and preventive actions.
- Supplier Quality Management:
- Collaborate with the procurement team to establish and maintain quality standards for raw materials and components.
- Conduct supplier audits to ensure compliance with quality requirements.
- Continuous Improvement Initiatives:
- Identify opportunities for process improvement to enhance overall product quality and manufacturing efficiency.
- Implement and track continuous improvement projects related to quality assurance.
- Quality Metrics and Reporting:
- Establish key performance indicators (KPIs) for quality assurance.
- Prepare regular reports on quality metrics, trends, and performance against targets.
- Customer Complaint Resolution:
- Manage the investigation and resolution of customer complaints related to product quality.
- Implement corrective actions to prevent recurrence.
- Regulatory Compliance:
- Stay informed about changes in regulatory requirements and ensure that the quality system remains compliant.
- Prepare for and participate in regulatory inspections.
- Validation and Qualification:
- Oversee the validation and qualification of equipment, processes, and analytical methods.
- Ensure that validation protocols and reports are maintained and up-to-date.
- Environmental Monitoring:
- Establish and maintain environmental monitoring programs to ensure product safety and quality.
- Implement controls to prevent contamination during manufacturing processes.
Qualifications:
- Bachelor’s or Master’s degree in Quality Assurance, Biochemistry, or a related field.
- Proven experience in quality assurance within a bio-organic manufacturing setting.
- In-depth knowledge of fermentation, extraction, and formulation processes.
- Familiarity with regulatory requirements in the bio-organic industry.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Experience with quality management systems and tools.
- Attention to detail and a commitment to continuous improvement.
Additonal Requirement:
Quality Assurance qualification MSc Chemistry with 10+years of relevant experience is setting standards.
