Job Description

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We are looking for a detail-oriented and proactive Quality Assurance Executive to join our Quality Assurance (QA) team. In this role, you will be responsible for ensuring that all products meet the highest standards of quality, safety, and compliance. You will work closely with various departments, including production, regulatory affairs, and quality control, to ensure consistent product quality and adherence to industry regulations. The ideal candidate will have strong knowledge of quality assurance processes and a passion for maintaining excellence in product quality.

Key Responsibilities:

Quality Assurance Monitoring and Auditing:

• Conduct regular audits of manufacturing processes, materials, and finished products to ensure compliance with quality standards and regulatory requirements (e.g., GMP, ISO).
• Perform internal audits of systems, processes, and documentation to ensure they align with company policies and industry best practices.
• Ensure adherence to quality standards by reviewing and approving batch records, manufacturing instructions, and quality control documentation.

Process Improvement and Compliance:

• Identify opportunities for process improvements and work with cross-functional teams to implement corrective and preventive actions (CAPAs).
• Monitor and evaluate the effectiveness of CAPAs and assist in resolving quality-related issues.
• Develop, update, and ensure compliance with standard operating procedures (SOPs) related to quality assurance and product quality.

Product and Supplier Qualification:

• Conduct supplier evaluations and audits to ensure suppliers meet required quality standards and regulatory guidelines.
• Assist in the qualification and validation of new materials, components, and suppliers.
• Ensure that all incoming raw materials and components meet quality specifications before they are used in production.

Regulatory Compliance:

• Ensure compliance with all regulatory requirements and industry standards (e.g., FDA, EMA, ISO, and local regulations).
• Assist in the preparation of regulatory submissions and documentation for product registrations and audits.
• Monitor regulatory changes and update internal quality systems to stay compliant with new laws and guidelines.

Documentation and Reporting:

• Prepare and maintain detailed quality assurance reports, audit reports, inspection findings, and compliance records.
• Maintain accurate documentation of quality assurance activities, ensuring data integrity and accessibility.
• Provide regular updates and reports to management on the status of quality-related initiatives and key performance indicators (KPIs).

Training and Development:

• Provide training and support to production and other departments on quality standards, regulatory requirements, and best practices.
• Stay up-to-date with the latest developments in quality assurance methodologies, industry regulations, and technological advancements.
• Promote a culture of quality across the organization by emphasizing the importance of quality at all stages of production and product development.

Risk Management:

• Conduct risk assessments and analyses to identify potential risks in manufacturing processes and product quality.
• Collaborate with the production team to implement risk mitigation strategies and ensure that quality is not compromised at any stage of production.

Skills and Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related field.
• [Insert Number] years of experience in quality assurance, preferably in [Insert Industry Type, e.g., Pharmaceuticals, FMCG, Medical Devices].
• Strong knowledge of quality management systems (QMS), ISO 9001, GMP, and relevant industry-specific regulations (e.g., FDA, EMA).
• Proven experience in conducting audits, managing CAPA processes, and handling regulatory compliance.
• Excellent problem-solving skills and the ability to make data-driven decisions.
• Strong attention to detail and organizational skills to manage multiple tasks and priorities effectively.
• Good understanding of statistical process control (SPC), risk management techniques, and validation protocols.
• Strong communication and interpersonal skills to work effectively with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint), as well as familiarity with quality management software and systems.

Job Type: Full-time

Pay: ?18,000.00 - ?22,000.00 per month

Benefits:

• Cell phone reimbursement

Schedule:

• Day shift

Education:

• Bachelor's (Preferred)

Experience:

• total work: 1 year (Preferred)

Work Location: In person

Application Deadline: 23/11/2024
Expected Start Date: 23/11/2024