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Senior Quality Assurance Officer
We are hiring a Senior Quality Assurance Officer to support day-to-day QA activities within a pharmaceutical manufacturing environment.
The role focuses on deviation management, CAPA, GMP compliance, and quality systems to ensure products and processes meet internal and regulatory requirements.
Main Responsibilities
• Handle deviations and non-conformities: support/lead investigations, perform root cause analysis (RCA), and document findings.
• Conduct impact and risk assessments for quality events and recommend appropriate actions.
• Manage and follow up on CAPA: ensure actions are implemented on time and verify effectiveness.
• Support GMP compliance in manufacturing and packaging areas through routine follow-up and coordination with production teams.
• Maintain QA documentation: review and/or approve change controls, SOPs, records, and related quality documents as per procedures.
• Participate in internal audits and support audit readiness; coordinate follow-up on audit observations and action plans.
• Support regulatory inspections by preparing required documents, ensuring traceability, and responding to requests in coordination with the team.
• Track quality KPIs and perform basic data trending to identify recurring issues and improvement opportunities.
• Prepare clear reports and communicate updates to stakeholders.
Qualifications & Requirements
• Bachelor’s degree in Industrial Engineering, Chemical Engineering, Pharmacy, or a related scientific field.
• 5+ years’ experience in QA within the pharmaceutical industry (manufacturing environment).
• Practical knowledge of GMP and quality systems (deviation, CAPA, change control, documentation, audits).
• Good understanding of manufacturing and packaging processes.
• Strong written communication and reporting skills.
• Ability to work with cross-functional teams and follow up effectively.
• Knowledge of risk management principles (e.g., ICH guidelines) is an advantage.