Quality Compliance Officer
6 months ago
As a Quality Compliance Officer in our manufacturing facility, you will play a pivotal role in ensuring the highest standards of quality, compliance, and operational excellence. You will be responsible for the development, implementation, and continuous improvement of our Quality Management System, helping to maintain and enhance product quality, regulatory compliance.
Key Responsibilities:
***
**QMS Development and Compliance**:
Develop, implement, and maintain the Quality Management System in accordance with relevant industry standards and regulatory requirements.
Establish and document quality policies, procedures, and processes to ensure consistency and compliance across the organization.
Ensure the QMS remains aligned with evolving industry standards and regulatory requirements.
Monitor changes in quality regulations and standards and update the QMS accordingly.
**Quality Documentation**:
Write, review, and maintain Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs) to ensure clarity and compliance.
Manage the creation, revision, and control of quality documents, including Standard Operating Procedures (SOPs), work instructions, and quality records.
Ensure that all documentation is accurate, up-to-date, and accessible to authorized personnel.
**Deviations**:
Documenting and reviewing all QMS activities, such as deviations, change controls, etc.
Lead the investigation and resolution of quality deviations, non-conformance's, and incidents.
**Audits and Inspections**:
Lead and support follow-up activities after audits, including tracking and closure of audit findings.
Ensure that audit responses and corrective actions are documented and implemented effectively.
Plan and conduct internal audits to assess QMS compliance and identify areas for improvement.
Assist in preparing for and participating in external audits and regulatory inspections.
**Continuous Improvement**:
Monitor key performance indicators (KPIs) and metrics to track the effectiveness of the QMS and initiate improvements as needed.
**Risk Management**:
Collaborate with teams to identify and assess risks related to product quality and regulatory compliance.
Implement risk mitigation strategies and monitor their effectiveness.
**Change Control**:
Oversee the change control process to ensure that changes to processes, equipment, or documentation are managed in compliance with the QMS.
**GMP Compliance**:
Maintain a comprehensive understanding of Good Manufacturing Practices (GMP) and ensure strict adherence to GMP standards throughout all quality management activities.
Continuously monitor and update quality procedures to align with GMP guidelines and regulations, fostering a culture of GMP compliance within the organization.
**Qualifications**:
Matric or higher with a minimum of 3 years of relevant experience.
Proficiency in unit conversions (e.g., grams to milligrams to kilograms).
Strong knowledge of quality standards and regulations relevant to the industry.
Excellent organizational skills.
Proficient in documentation control and management systems.
Effective communication and interpersonal skills.
Detail-oriented and committed to maintaining high standards of quality.
Certification or Diploma in Quality Management is advantageous
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