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Senior Manager

2 months ago

Billerica, Massachusetts, United States Sun Pharma Full time

Job Summary:

The Senior Manager - Pharmaceutical Operations will oversee the visual inspection, labeling, and packaging of parenteral pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs). This role will also manage the warehouse shipping/receiving team and direct shift leads and floor personnel to improve safety, quality, and performance.

Key Responsibilities:

  • Directly oversee shift leads and floor personnel to ensure adherence to cGMPs and SOPs.
  • Manage all kit inspection, packaging, and labeling operations in accordance with commercial forecast and Operations Director's direction.
  • Plan, lead, manage, prioritize, and organize work in the ILP and warehouse operations teams.
  • Work cohesively with the Sr. Production Manager to ensure packaging area scheduling aligns with production goals.
  • Assign daily duties to team members to accomplish production goals and utilize personnel effectively.
  • Ensure all staff training and qualifications for Visual Inspection are up-to-date.
  • Resolve routine to complex inspection and packaging issues and/or equipment problems with staff and/or other departments in a timely fashion.
  • Revise batch records and SOPs as needed to improve efficiency and quality of manufacturing/packaging process.
  • Use systems like SAP, Track-Wise, EDMS, and Master Control to manage operations.
  • Initiate/Author and complete Deviations, Change Control, CAPAs, and other documentation as required.
  • Update computer data for packaging department to record production inventory, results, dates, problems, etc.
  • Review all in-process documentation for accuracy.
  • Ensure proper operation of Inspection/Labeling/Packaging equipment.
  • Plan and order supplies for production to assure timely completion of production goals.
  • Make recommendations on efficiency and cost as appropriate.
  • Work under minimal direct supervision, utilizing standard procedures and own judgment.
  • Prioritize safety and maintain good housekeeping in the ILP working area and warehouse.
  • Oversee all phases of the Change Control process for owned changes.
  • Hire, train, manage, and motivate staff to meet production and warehouse demands.

Work Conditions:

  • Office
  • Shop/Shipping area
  • Controlled/Manufacturing area

Physical Requirements:

  • Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
  • Climb or balance, stoop, kneel, crouch or crawl, talk or hear, taste or smell
  • Close, color, and peripheral vision, depth perception, ability to adjust focus
  • Correctable 20/20 vision
  • Ability to visually inspect small products and print
  • Be able to multitask
  • Operate label application machinery, thermal transfer printer, computer, serialization, and heat sealing equipment
  • Operate computer/office machines
  • Proper gowning, Safety shoes, safety glasses, gloves
  • Lift up to 30 lbs.

Travel Estimate:

Up to 5%

Education and Job Qualification:

  • B.S. required
  • Must possess current, valid class D Driver's license
  • Ability to operate and maintain all process equipment
  • Familiarity with FDA cGMP, SOPs, and ISO standards
  • Knowledge of pharmaceutical labeling/packaging equipment and warehouse operations

Experience:

  • Minimum 8-10 years related experience with minimum 4-6 years in a supervisory and/or managerial role required
  • Direct experience with manual visual inspection for small volume parenteral required
  • Strong computer skills