Job Title: Quality and Regulatory Compliance Specialist
Key Responsibilities:
- Ensure the effective implementation of Quality Management Systems to ensure compliance with regulatory requirements across pharmaceutical and medical device operations.
- Support the development, maintenance, and implementation of Regulatory Policies and procedures to ensure adherence to Good Distribution Practice (GDP) and local regulations.
- Conduct regular Audits and CAPA investigations to identify areas for improvement and implement corrective actions to maintain compliance with regulatory standards.
- Manage pharmacovigilance activities, including adverse event reporting and follow-up, in accordance with regulatory requirements and internal procedures.
- Oversee the validation of systems, equipment, and processes involved in distribution to ensure data integrity and compliance with regulatory standards.
- Develop and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies, ensuring that training records are complete and up-to-date.
- Qualify and manage suppliers and third-party service providers, including audits and performance monitoring, to ensure compliance with regulatory standards.
- Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling.
- Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution by performing product release checks and managing change control processes.
- Provide regulatory support, including preparing, submitting, and maintaining facility licenses, registrations, and renewals with national and international regulatory bodies.
- Monitor regulatory updates and assess business impact (regulatory intelligence) to ensure proactive compliance with changing regulatory landscapes.
Requirements:
* Qualified Pharmacist with a strong understanding of GDP, GMP, MDR, IVDR, and local regulatory frameworks.
* Responsible Person eligibility and 1-3 years working in a similar role; Quality, Compliance (Pharma/Medical Device Business).
* Auditor certified (e.g., ISO 9001 and/or ISO 13485 or Pharma Equivalent).
* Strong knowledge of Pharmacovigilance and Medical Information principles and practices.
* Excellent communication, organizational, and interpersonal skills.
* Ability to work effectively in a team environment and prioritize tasks under pressure.
* Proficient in Microsoft Office and other relevant software applications.
Benefits:
- Annual bonus scheme and performance-related bonuses.
- Comprehensive pension plan.
- Group life assurance policy.
- Health insurance and wellbeing initiatives.
- Flexible working arrangements, including remote work options and flexible hours.
About Us:
We are an independent recruitment agency dedicated to providing exceptional service to our clients and candidates. We adhere to a strict code of practice and respect the confidentiality of our applicants' details.
How to Apply:
If you are interested in this exciting opportunity, please submit your CV through the provided link. We look forward to reviewing your application.
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Keywords: Quality Specialist, Regulatory Specialist, Compliance, Good Distribution Practice, Pharmacist, Pharmacovigilance, Responsible Person, Quality Management Systems, Audits, MDR, IVDR, ISO 9001, ISO 13485.