Quality Specialist

Key Responsibilities:

• Ensure full compliance with Good Storage and Distribution Practices (GSDP) and all applicable regulatory requirements.
• Develop, implement, and continuously enhance the QMS.
• Manage quality events, including deviations, CAPA, change controls, and risk assessments.
• Conduct internal audits and actively participate in external audits and regulatory inspections.
• Act as a key point of contact during regulatory inspections, ensuring continuous inspection readiness.
• Maintain and control all quality documentation, including SOPs, policies, and records.
• Oversee supplier qualification, audits, and ongoing performance monitoring.
• Ensure proper storage, handling, and distribution conditions to maintain product quality and integrity.
• Review and release pharmaceutical products in compliance with approved procedures and regulatory requirements.
• Provide quality oversight of logistics operations and warehouse activities, ensuring compliance with GSDP and ISO standards.
• Manage customer complaints, perform investigations, and ensure timely resolution and follow-up.
• Oversee temperature mapping, validation activities, and compliance with storage requirements.
• Monitor and track Quality KPIs, ensuring timely reporting, analysis, and implementation of corrective actions to drive continuous improvement.
• Deliver and support training programs related to quality standards.
• Collaborate with cross-functional teams to ensure adherence to health authority regulations and internal policies.
• Drive continuous improvement initiatives and promote a strong quality culture across the organization.

Candidate Qualifications:

• Bachelor's degree in Pharmacy.
• 4–6 years of experience in Quality Assurance within the pharmaceutical industry.
• Proven hands-on experience in external audits and regulatory inspections.
• Strong knowledge of GDP/GSDP guidelines, QMS, regulatory requirements and ISO Standards.
• Demonstrated experience managing audits, inspections, and quality system processes.
• High attention to detail with strong analytical and problem-solving abilities.
• Excellent communication and interpersonal skills.
• Ability to work both independently and collaboratively in a team environment.