I have extensive experience in pharmaceutical production, having worked on various formulations and dosage forms. My background includes managing batch records, ensuring compliance with GMP regulations, and troubleshooting production issues. I have successfully led teams in scaling up production from pilot to commercial scale, ensuring consistency and quality in every batch.

Ensuring compliance with regulatory requirements is a top priority. I regularly review and update Standard Operating Procedures (SOPs) to align with current regulations. I also conduct regular audits and training sessions to ensure all team members are aware of and adhere to these standards. Additionally, I maintain thorough documentation and records to demonstrate compliance during inspections.

Maintaining product quality involves a multi-faceted approach. I implement rigorous quality control measures, including in-process testing and final product inspections. I also ensure that all raw materials meet specifications before use. Continuous monitoring and calibration of equipment, along with regular staff training on quality standards, are essential components of my strategy.

When deviations occur, I follow a systematic approach to address them. First, I document the issue thoroughly and identify its root cause. Next, I implement corrective actions and preventive measures to mitigate the issue. I also ensure that all affected batches are reviewed and, if necessary, quarantined until the issue is resolved. Finally, I update SOPs to prevent recurrence and conduct a debrief with the team to learn from the experience.

I have experience working with advanced technologies and automation in pharmaceutical production. I have implemented automated systems for mixing, filling, and packaging, which have improved efficiency and reduced human error. I am also proficient in using software for batch tracking, inventory management, and data analysis. My experience includes integrating new technologies into existing workflows while ensuring they meet regulatory standards.