Quality Assurance Officer

Key Responsibilities:

Quality Systems Management:

• Implement and maintain Good Manufacturing Practices (GMP) in compliance with regulatory requirements (e.g., WHO, USFDA, MHRA).
• Ensure all processes and systems meet regulatory, corporate, and client quality standards.
• Manage and monitor the quality management system (QMS), including change control, deviations, CAPA, and risk assessments.

Documentation & Compliance:

• Prepare, review, and update Standard Operating Procedures (SOPs) and quality assurance policies.
• Conduct internal audits and coordinate external audits and regulatory inspections.
• Maintain and ensure timely submission of quality documentation, including batch records, validation protocols, and reports.

Product Quality Oversight:

• Perform in-process checks during manufacturing and packaging to ensure adherence to specifications.
• Review and approve batch records and certificates of analysis (COA) before product release.
• Investigate non-conformances and implement corrective and preventive actions (CAPA).

Validation & Qualification:

• Support validation activities for equipment, processes, and cleaning procedures.
• Participate in qualification of facilities, utilities, and equipment.

Training & Team Collaboration:

• Train staff on quality-related topics, including GMP and compliance requirements.
• Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to ensure quality objectives are met.

Regulatory Compliance:

• Stay updated on current pharmaceutical regulations and quality guidelines.
• Ensure adherence to regulatory requirements for product registrations and submissions.

Qualifications:

• Bachelors or Master’s degree in Pharmacy or a related field.
• Certification in GMP, ISO 9001, or other relevant quality standards is an advantage.
• 2 to 4 years of experience in quality assurance in the pharmaceutical industry.

Key Skills:

• Strong knowledge of GMP, GLP, and regulatory requirements (e.g., FDA, EMEA).
• Excellent documentation and analytical skills.
• Proficiency in quality tools and techniques, including root cause analysis and CAPA.
• Attention to detail and problem-solving abilities.
• Effective communication and interpersonal skills.