Summary
Date Posted: Thursday, October 26 2023, Base Salary: Not Disclosed

JOB DETAILS:
JOB SUMMARY
As a QA Specialist, your primary role is to ensure rigorous quality oversight across development, operations, laboratories, and validation groups. You will be responsible for meticulously reviewing, approving, and releasing records, reports, and completed tasks. Your focus will extend to process approvals, extensive documentation, inspections, and active participation in both internal and external audits. Your expertise will play a pivotal role in qualification processes, contributing to the overall quality assurance framework of the organization.

DUTIES AND RESPONSIBILITIES
• Provide guidance to development, operations, laboratories, and validation groups for compliance with quality standards and regulatory requirements such as GMP and GLP.
• Conduct regular reviews and approvals of records, reports, and completed tasks for accuracy and adherence to procedures, ensuring the timely release of tasks.
• Collaborate with development teams during design and prototyping, participating in reviews to ensure products meet quality requirements.
• Support operations teams in implementing and maintaining quality control measures on the production floor through periodic inspections.
• Work closely with laboratory teams to ensure testing protocols and procedures meet quality standards; review and approve laboratory reports for accuracy and compliance.
• Oversee the validation of equipment, processes, and systems, reviewing and approving protocols and reports to ensure regulatory compliance.
• Identify and implement opportunities for process improvements, collaborating with cross-functional teams to enhance the overall quality management system.
• Provide training to employees on quality systems, procedures, and regulatory guidelines. Ensure that all personnel involved in manufacturing and quality processes are aware of their responsibilities.
• Participate in internal and external audits, responding to audit findings and implementing corrective actions especially related to quality control tests, procedures, and laboratory equipment

Qualifications & Experience
• Bsc. Pharmacy/Biomedical Engineering/Chemical Engineering/Biology/Biotechnology
• Bachelor's degree in a relevant field (e.g., Quality Management, Engineering, Life Sciences).
• Knowledge of the production SAP is an added advantage
• Proven experience of 7 years in quality assurance within the medical equipment manufacturing industry.
• Strong knowledge of regulatory requirements such as NDA, WHO and ISO 13485, ISO 9001.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
• Proficient in MS Office suite ie Word, Excel, Power-point.



Work Hours: 8

Experience in Months: 84

Level of Education: Bachelor Degree

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