Job Title
As a Compliance Specialist, you will be responsible for ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations.
* Maintain and control documentation, including SOPs, records, and batch release documents.
* Lead and participate in internal and external audits, including preparation, execution, and follow-up on findings.
* Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies.
* Monitor regulatory updates and assess business impact.
* Review and approve product labeling, promotional materials, and advertising to ensure regulatory compliance.
* Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up.
Key qualifications include:
* Qualified Pharmacist.
* Responsible Person eligibility.
* 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).
The successful candidate will have strong knowledge of GDP, GMP, MDR, IVDR, and Local Regulatory Framework.
This is an exciting opportunity to leverage your expertise in regulatory compliance and join a forward-thinking organization that prioritizes quality and patient safety.