Deputy General Manager

7 days ago


Indiana, Pennsylvania, United States Sun Pharmaceutical Industries, Inc. Full time

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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