Deputy General Manager
7 days ago
Job Summary:
Sun Pharmaceutical Industries, Inc. is seeking a highly skilled Deputy General Manager to lead our site engineering operations. As a key member of our team, you will be responsible for managing maintenance, overseeing technical bid analysis, and ensuring compliance with cGMP and USFDA standards.
Key Responsibilities:
- Manage maintenance for OSD utilities, plant equipment, electrical systems, instrumentation, calibration, HVAC, civil design, and oversee overall site engineering operations.
- Lead an engineering team, overseeing technical bid analysis, budget preparation, and comparing equipment specifications.
- Review P&ID drawings and proactively identify breakdown-prone areas, implementing preventive measures and maintaining root cause analysis reports.
- Provide guidance to the QMS team for deviation investigation, change control, and CAPA implementations.
- Manage equipment, HVAC, and utility qualification/validation, as well as oversee requalification processes.
- Ensure strict compliance with cGMP and USFDA standards for safety and environmental practices.
- Conduct activities related to material and energy balances, conceptual layouts, and oversee system audits.
- Implement various safety measures to minimize incidents and document conceptual details through monthly safety meetings.
- Accountable for monthly reports on plant efficiency and breakdown analysis.
- Accountable for various cGMP audits and compliance assessments, including those conducted by USFDA.
- In charge of Computerized System Validation (CSV) in accordance with GAMP 5 standards.
Requirements:
- Background exclusively in the Pharma Industry, with specific experience in Oral Solid Facility operations.
- Experience in managing engineering and maintenance activities for a Large Volume block.
- Desired candidate should possess exposure to regulatory audits, specifically with experience in USFDA audits.
- Track record of managing a team of 50-60 individuals across engineering and maintenance departments.
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