QA Analyst Bachelor Degree Job

Job Summary

The QA Analyst will be responsible for ensuring that products are manufactured and tested in compliance with regulatory standards and internal quality procedures.
This role involves the review and approval of manufacturing processes, documentation, and product quality to ensure the highest standards are maintained.

Key Responsibilities

Quality Systems Management:

Develop, implement, and maintain quality systems and processes in accordance with GMP and regulatory requirements.
Ensure compliance with internal and external quality standards, including FDA, WHO, and other regulatory requirements.

Documentation and Record Review:

Review and approve batch records, production records, and other GMP documentation.
Maintain accurate and detailed records of all quality-related activities and ensure proper documentation control.

Process and Product Audits:

Conduct internal audits of manufacturing processes and systems to ensure compliance with SOPs, GMP, and regulatory requirements.
Participate in external audits and inspections conducted by regulatory bodies.

Deviation and CAPA Management:

Investigate deviations and non-conformances, determine root causes, and implement corrective and preventive actions (CAPAs).
Monitor the effectiveness of CAPAs and report on their status.

Change Control:

Manage and document changes to manufacturing processes, equipment, and systems.
Assess the impact of changes on product quality and regulatory compliance.

Training:

Develop and deliver training programs on GMP, quality systems, and regulatory requirements.
Ensure all staff are adequately trained and maintain training records.

Quality Improvement:

Identify areas for continuous improvement in quality systems and processes.
Implement quality improvement initiatives and monitor their effectiveness.

Risk Management:

Conduct risk assessments related to product quality and manufacturing processes.
Develop and implement risk mitigation strategies.

Complaint Handling:

Investigate product complaints and coordinate with relevant departments to resolve issues.
Maintain records of complaints and report trends to management.

Supplier Quality Management:

Evaluate and approve suppliers and contractors.
Conduct audits and monitor the performance of suppliers to ensure compliance with quality standards.

Qualifications

Education: Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
Experience: At least 3-5 years of experience in a quality assurance role in the pharmaceutical industry.
Technical Skills: Strong knowledge of GMP, GLP, and regulatory requirements. Experience with quality management systems and auditing.
Soft Skills: Excellent attention to detail, strong analytical and problem-solving skills, effective communication, and ability to work independently and as part of a team.


go to method of application »

HRLeverage Africa is in tune with the global shakeups and as such we also provide solution to talented staff who may have been affected by a downsized organization. As part of your severing policy, you can consult us to help you search for better career opportunities for your recently out placed ... read morestaff. We have the passion and ability to educate, mentor, coach and provide executive search services to executives who have been downsized. It is the right personal and professional service needed in this turbulent and uncertain job market. With our years in the industry, our level of expertise is through our success stories with the mid and senior-level (manager, director, vice president, president, C-level) professionals. We understand that the process of a career change, or exit of employees from their former employers, can be a trying time due to the stress and cost involvement. HRLeverage supports you to assess the present situation, analyze available options, develop transformation strategies and execute the strategies so that go through the transition process with ease. Our services address the following POCE strategies to help Executives effectively manage a job search