
Senior Pharmaceutical Quality Assurance Specialist
5 days ago
Job Summary:
">- A quality assurance expert is required to lead our laboratory operations and ensure the highest standards of quality.
Responsibilities:
">- Lab Operations: Supervise and manage daily laboratory activities, including sampling, testing, and documentation.
- Quality Compliance: Ensure strict adherence to cGMP, GLP, and relevant regulatory requirements.
- Testing and Analysis: Manage analytical testing for raw materials, in-process, and finished goods.
- Documentation Review: Review and approve Standard Operating Procedures (SOPs), test methods, and related QC documentation.
- Collaboration: Liaise with QA, Production, and R&D departments to maintain quality standards.
- Regulatory Audits: Lead preparation and coordination for regulatory audits (e.g., DRAP, WHO).
- Continuous Improvement: Drive continuous improvement in lab practices and quality systems.
- CTD Dossiers: Must be able to design CTD dossiers.
Requirements:
">- Education: Pharm-D degree from a recognized institution.
- Experience: Minimum 4 years of experience in pharmaceutical Quality Control.
- Skills: Proficiency with analytical instruments like HPLC, UV spectrophotometer and dissolution testers.
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