Sterile Production - Senior Executive

USV PRIVATE LIMITED; Daman; On-site; INR 900,000 - 1,300,000; Full time

Job summary

USV PRIVATE LIMITED in India is seeking a hands-on supervisor to oversee aseptic manufacturing, including formulation, filtration, filling and lyophilization, in a strict cGMP cleanroom setting.

You will review BMRs and SOPs to ensure data integrity and regulatory compliance, investigate deviations, and implement CAPAs with QA support. You will also train shop-floor operators in cleanroom conduct and aseptic techniques to maximize efficiency and prevent contamination.

Responsibilities

• Oversee aseptic manufacturing processes, including formulation, filtration, filling, and lyophilization, ensuring strict adherence to cGMP guidelines and cleanroom protocols.
• Review and manage critical documentation, such as Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs), to guarantee real-time data integrity and regulatory compliance.
• Investigate production deviations and implement Corrective and Preventive Actions (CAPAs) in collaboration with Quality Assurance to maintain product sterility and resolve operational issues.
• Train and supervise shop-floor operators on proper cleanroom behavior, advanced aseptic techniques, and equipment operation to maximize efficiency and minimize contamination risks.

Job description

• Oversee aseptic manufacturing processes, including formulation, filtration, filling, and lyophilization, ensuring strict adherence to cGMP guidelines and cleanroom protocols.
• Review and manage critical documentation, such as Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs), to guarantee real-time data integrity and regulatory compliance.
• Investigate production deviations and implement Corrective and Preventive Actions (CAPAs) in collaboration with Quality Assurance to maintain product sterility and resolve operational issues.
• Train and supervise shop-floor operators on proper cleanroom behavior, advanced aseptic techniques, and equipment operation to maximize efficiency and minimize contamination risks.