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Quality Control Senior Analyst
2 months ago
Company Overview
Sun Pharma is a prominent global pharmaceutical organization dedicated to enhancing health and well-being worldwide. Our commitment to quality and innovation drives us to deliver a diverse range of pharmaceutical products that meet the highest standards of safety and efficacy.
Position Overview
The Senior Analyst in Quality Control plays a pivotal role in overseeing the implementation and maintenance of a comprehensive quality program that aligns with both internal and regulatory standards. This position is essential in fostering a culture of quality excellence within the manufacturing environment.
Key Responsibilities
Team Leadership Focus:
- Supervise a team of analysts to perform GMP laboratory testing, offering guidance and technical expertise.
- Facilitate the introduction of new laboratory protocols and technologies to enhance operational efficiency.
- Address and resolve issues related to testing methods and laboratory equipment.
- Manage the complete cycle of internal laboratory investigations, including data analysis and corrective actions.
- Provide training on analytical methods and assist in onboarding new team members.
- Conduct testing for in-process, bulk, finished goods, stability, and validation samples.
- Oversee method transfer activities to ensure compliance and effectiveness.
- Collaborate with the Quality Control Supervisor to prioritize tasks and communicate effectively with the team.
- Support internal and regulatory audits to ensure adherence to quality standards.
- Design and implement training programs to enhance team capabilities and compliance with regulatory requirements.
- Identify opportunities for process improvements to elevate quality standards and operational efficiency.
- Perform additional duties as required.
Development Focus:
- Lead the development and validation of analytical methods within the QC laboratory, focusing on HPLC and other instrumental techniques.
- Establish and validate cleaning procedures as necessary.
- Conduct IV drug release testing for comparative analysis.
- Manage process and cleaning validation testing.
- Oversee method transfer initiatives and new product introductions.
- Address troubleshooting for products, methods, and raw materials.
- Lead projects aimed at process enhancements within the quality control domain.
- Work closely with the Quality Control Supervisor to coordinate team priorities and workload.
- Act as a Subject Matter Expert, providing technical support and mentorship to team members.
- Develop a job rotation schedule to ensure comprehensive training for QC Analysts across all programs.
Join us in our mission to deliver high-quality healthcare solutions that make a difference in the lives of patients globally.
