Senior QC Manager
8 hours ago
We are seeking a highly skilled and experienced Senior Quality Control (QC) Manager with expertise in the API (Active Pharmaceutical Ingredient) industry. The ideal candidate will play a key role in maintaining the highest quality standards, ensuring regulatory compliance, and driving continuous improvement in the QC processes. As the Senior QC Manager, you will oversee a team responsible for monitoring product quality, performing audits, and managing the overall quality control strategy for API manufacturing.
Role & responsibilities
- Lead, manage, and mentor the Quality Control (QC) team in the API manufacturing department
- Develop, implement, and enforce stringent quality control policies, procedures, and standards that comply with GLP
- Hand on experience with HPLC, GC,UV,IR,KF and other analytical instrument.
- Oversee the testing and release of raw materials, intermediates, and finished API products to ensure adherence to specifications and regulatory standards.
- Lead investigations of deviations, non-conformances, and product complaints, ensuring that CAPAs (Corrective and Preventive Actions) are thoroughly addressed.
- Develop and execute risk assessments, stability studies, and validation protocols for API processes
- Conduct internal and external audits to assess the compliance of the manufacturing processes and quality control practices.
- Prepare and maintain comprehensive documentation related to product testing, QC processes, and regulatory submissions.
- Lead the implementation of continuous improvement projects within the QC department.
- Provide training to QC staff on GMP, safety, and quality control techniques.
Preferred candidate profile
- Masters degree in Chemistry or a related field.
- Minimum of 8-10 years of experience in quality control within the API (Active Pharmaceutical Ingredients), with at least 3-5 years in a leadership role.
- Familiarity with quality management software and laboratory information management systems (LIMS)
Interested Candidates can send resume at or Contact
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