Quality Specialist
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Key skills for this role
About the Role
The employer is seeking a Quality Specialist to ensure compliance with GSDP and regulatory requirements in the pharmaceutical industry. The role involves managing QMS, conducting audits, and overseeing quality documentation.
Key Skills for This Role
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
Requirements
- 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
Full Job Posting
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.
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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