Quality Specialist
Skills
About This Role
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.
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