Quality Assurance Officer at Shalina Healthcare

Job Summary:

• The QA Officer is responsible for ensuring that all pharmaceutical products are manufactured in compliance with cGMP (current Good Manufacturing Practices), regulatory requirements, and internal quality standards. This role involves reviewing processes, procedures, and documentation to maintain the highest levels of product quality and safety.

Key Responsibilities:

• Ensure adherence to GMP, SOPs, and regulatory standards across all production activities.
• Review and approve batch manufacturing and packaging records.
• Conduct line clearance checks before the start of production and packaging.
• Participate in internal audits, self-inspections, and external regulatory inspections.
• Investigate and report deviations, incidents, and non-conformances.
• Coordinate change controls, CAPAs (Corrective and Preventive Actions), and product complaints.
• Monitor and ensure implementation of environmental monitoring and calibration programs.
• Participate in supplier/vendor qualification and audits.
• Review validation protocols and reports (process, cleaning, equipment, etc.).
• Ensure the implementation and training of GMP and quality systems.
• Maintain QA documentation and manage document control processes.
• Support continuous improvement initiatives within the quality management system.

Qualifications and Experience:

• B.Pharm, B.Sc in Chemistry, Microbiology, Biochemistry, or related field.
• 2–5 years' experience in QA roles within a pharmaceutical manufacturing environment.
• Good knowledge of GMP, GDP, GLP, and regulatory requirements (e.g., NAFDAC,PCN
• Familiarity with quality systems (ISO, QMS, etc.).

Key Competencies:

• Attention to detail and analytical thinking.
• Strong documentation and communication skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office and basic QA software tools.
• Problem-solving and decision-making abilities.