Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
1 year ago

Additional Details

Job ID
95047
Job Views
118

Job Description



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.


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