- Ensure compliance with regulatory requirements, company policies, and procedures related to production manufacturing, quality management systems (QMS), change control, deviation management, market complaints handling, OOS/OOT investigations, and OSD.
- Develop and implement effective strategies for improving productivity, reducing costs, and enhancing overall efficiency in the production process.
- Collaborate with cross-functional teams to identify areas of improvement and drive continuous process improvements through root cause analysis and corrective actions.
- Conduct regular audits and inspections to ensure adherence to cGMP guidelines and maintain accurate records of all documentation.
- Provide technical support to junior team members on various aspects of production operations.
Desired Candidate Profile
- 7-9 years of experience in pharmaceutical industry with expertise in BMR/BPR review, change control processes, CAPA implementation, deviation management system operation.
- Bachelor's degree in a relevant field such as B.Tech Computers or equivalent qualification.
- Solid understanding of QMS principles including ISO standards; knowledge of OSD regulations would be an added advantage.