Sterile Production - Senior Executive

PeopleStrong; Daman; On-site; INR 600,000 - 900,000; Full time

Job summary

PeopleStrong seeks an experienced supervisor to oversee aseptic manufacturing operations, ensuring strict adherence to cGMP and cleanroom protocols. You will review critical process documentation, investigate deviations, and drive CAPAs with QA.

The role includes training and supervising shop-floor operators to uphold sterility and efficiency. Ideal candidates have hands-on aseptic manufacturing experience, strong documentation skills, and a proven ability to lead a team in a highly regulated

Qualifications

• Aseptic manufacturing experience with strict cGMP adherence.
• Experience reviewing Batch Manufacturing Records and SOPs for data integrity.

Responsibilities

• Oversee aseptic manufacturing processes including formulation, filtration, filling and lyophilization.
• Review and manage critical documentation (BMRs, SOPs) to ensure regulatory compliance.
• Investigate production deviations and implement CAPAs with QA.
• Train and supervise shop-floor operators on cleanroom behavior and equipment use.

Skills

Aseptic manufacturing

cGMP compliance

Cleanroom protocols

Documentation review

CAPA implementation

Operator training

Team supervision

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.