Good Knowledge of USFDA/ EDQM /ANVISA / and all other regulatory & CGMP awareness.
- Strategic oversight and leadership: Develop and implement the company's quality management system (QMS) and strategy, aligning it with business objectives. This includes overseeing all aspects of quality operations and managing the QA and QC departments.
- Regulatory compliance: Ensure strict adherence to national and international regulatory requirements, such as Current Good Manufacturing Practices (cGMP). This involves preparing for, managing, and leading regulatory and customer audits.
- Quality operations management: Oversee daily quality operations, including the release or rejection of finished APIs and intermediates. They also ensure timely testing of materials and products through robust QC procedures.
- Deviation and change control: Manage critical quality processes, such as handling change control activities, investigating deviations,
implementing Corrective and Preventive Actions (CAPA), and managing product complaints and recalls.
- Process improvement and validation: Collaborate with R&D; and technology transfer teams to optimize processes, improve product yield, and ensure successful scaling up of recent products. They also oversee the validation of new and modified processes.
- Audits and inspections: Act as the primary point of contact for regulatory inspections and customer audits, providing supporting documentation and ensuring all compliance requirements are met.
- Team management: Lead, mentor, and develop a team of quality professionals. This includes overseeing training programs to ensure the team is fully aligned with quality protocols and Standard Operating Procedures (SOPs).