Quality Assurance Officer job at Microhaem Scientifics and medical supplies

JOB PURPOSE:

The Quality Assurance Officer is responsible for ensuring that all products and processes adhere to quality standards and regulatory requirements. The role is vital in maintaining the integrity of MHS products and in upholding Company’s commitment to producing safe and effective products. The successful candidate will play a critical role in maintaining compliance with GMP, ISO, and Internal Quality Management System (QMS) requirements, while actively supervising production activities to ensure consistent product quality, safety, and regulatory compliance.

DUTIES AND RESPONSIBILITIES:

Production & Shop Floor Supervision: Maintain a strong QA presence on the production floor, overseeing manufacturing, packaging, and labeling activities. Ensure strict adherence to approved SOPs, batch records, and work instructions during production

Quality Compliance: Monitor and ensure compliance with all relevant regulations, guidelines, and industry standards for pharmaceutical manufacturing and quality control.

Documentation Management: Maintain accurate and organized documentation related to quality control processes, including batch records, standard operating procedures (SOPs), and quality testing data.

Batch Record Review: Review batch records and associated documentation to ensure that products meet quality specifications before release for distribution.

Quality Audits: Participate in internal and external quality audits to assess compliance with regulatory requirements and identify areas for improvement.

CAPA Management: Contribute to the identification and implementation of Corrective and Preventive Actions (CAPA) in response to quality issues, deviations, and nonconformances.

Root cause and investigation: Identify the gaps or deviations in the system and follow up to ensure that they are resolved.

Change Control: Review and assess proposed changes to processes, equipment, or procedures to determine their potential impact on product quality and compliance.

Quality Training: Assist in the development and delivery of quality-related training programs for employees to enhance their understanding of quality principles and practices.

Validation Activities: Support validation activities, including equipment qualification, process validation, and cleaning validation, to ensure that processes are capable of consistently producing quality products.

Risk Assessment: Participate in risk assessment activities to identify potential quality risks and develop strategies to mitigate them.

Continuous Improvement: Contribute to the continuous improvement of quality systems by identifying opportunities for streamlining processes and enhancing efficiency.

QUALIFICATIONS & EXPERIENCE

• Bachelor’s degree in Pharmacy, Biomedical Engineering or related fields. Master’s degree is an added advantage.
• Previous experience (2+ years) in quality assurance within the pharmaceutical or related industry.
• Demonstrated experience in production QA and shop-floor quality supervision
• Familiarity with pharmaceutical regulations and guidelines, such as Good Manufacturing Practices (GMP) and International Council for Harmonisation (ICH) guidelines.
• Internal Audit Training/Certification will be an added advantage.

Technical Skill

• Ability to multitask
• MS Office Skills
• Ability to support cross-functional teams
• Strong Presentation Skill

Competencies

• Strong information retrieval and data analysis skills, as well as excellent official document writing abilities.
• Strong cross-team communication and external collaboration skill.
• Strong resilience, ability to face challenges and adapt to new procedures.

Key Attributes

• Responsiveness
• Analytical skills
• Problem Solving
• Ability to multitask
• Physical fitness and good health

• Maintain a strong QA presence on the production floor, overseeing manufacturing, packaging, and labeling activities. Ensure strict adherence to approved SOPs, batch records, and work instructions during production
• Monitor and ensure compliance with all relevant regulations, guidelines, and industry standards for pharmaceutical manufacturing and quality control.
• Maintain accurate and organized documentation related to quality control processes, including batch records, standard operating procedures (SOPs), and quality testing data.
• Review batch records and associated documentation to ensure that products meet quality specifications before release for distribution.
• Participate in internal and external quality audits to assess compliance with regulatory requirements and identify areas for improvement.
• Contribute to the identification and implementation of Corrective and Preventive Actions (CAPA) in response to quality issues, deviations, and nonconformances.
• Identify the gaps or deviations in the system and follow up to ensure that they are resolved.
• Review and assess proposed changes to processes, equipment, or procedures to determine their potential impact on product quality and compliance.
• Assist in the development and delivery of quality-related training programs for employees to enhance their understanding of quality principles and practices.
• Support validation activities, including equipment qualification, process validation, and cleaning validation, to ensure that processes are capable of consistently producing quality products.
• Participate in risk assessment activities to identify potential quality risks and develop strategies to mitigate them.
• Contribute to the continuous improvement of quality systems by identifying opportunities for streamlining processes and enhancing efficiency.

• Ability to multitask
• MS Office Skills
• Ability to support cross-functional teams
• Strong Presentation Skill
• Strong information retrieval and data analysis skills
• Excellent official document writing abilities
• Strong cross-team communication
• External collaboration skill
• Strong resilience
• Ability to face challenges
• Ability to adapt to new procedures
• Responsiveness
• Analytical skills
• Problem Solving
• Ability to multi-task
• Physical fitness and good health

• Bachelor’s degree in Pharmacy, Biomedical Engineering or related fields.
• Master’s degree is an added advantage.
• Previous experience (2+ years) in quality assurance within the pharmaceutical or related industry.
• Demonstrated experience in production QA and shop-floor quality supervision
• Familiarity with pharmaceutical regulations and guidelines, such as Good Manufacturing Practices (GMP) and International Council for Harmonisation (ICH) guidelines.
• Internal Audit Training/Certification will be an added advantage.