Location: Not Specified
Company: Not Specified
Position: Senior Manager – Production (Injectables)
Job Title: Senior Manager – Operations
Function: Manufacturing Formulation
Job Grade: Not Specified
Sub-function: Not Specified
Number of Direct Reports: Not Specified
Qualification:
B.Pharm
Experience:
Minimum 15+ years of experience in injectable manufacturing
Experience in USFDA-approved sites is mandatory
Job Summary:
The Senior Manager – Production (Injectables) is responsible for leading operations in Block-E, encompassing vial filling, PFS (Pre-filled Syringe) lines, infusion bag lines, API manufacturing area, aseptic processing, autoclave areas, freeze-drying zones, and qualification/re-qualification activities. The role includes complete oversight of production activities, documentation, QMS compliance, and equipment validations in the parenteral manufacturing block.
Key Responsibilities:
Oversee operations in Vial Filling Line, PFS Filling Line, Infusion Bag Line, API Line, Autoclave, Aseptic Area, and Freeze Drying zones in Block-E.
Lead all qualification and re-qualification activities related to equipment and areas within parenteral manufacturing.
Ensure adherence to cGMP documentation practices and maintenance of area/equipment logbooks.
Manage QMS-related activities including deviation handling, CAPA, and change control processes.
Authorized to sign GMP documents related to parenteral operations (as Doer, Reviewer, Approver).
Review and approve equipment cleaning/sanitization logs and breakdown memos with impact assessment.
Ensure cleanliness, readiness, and compliance of the parenteral production facility at all times.
Collaborate cross-functionally with QA, Engineering, Validation, and Regulatory Affairs for smooth execution of operations.
Train and guide production staff in sterile manufacturing practices and regulatory expectations.
Maintain audit readiness and support regulatory and internal inspections.
Perform any additional responsibilities as assigned by the Department Head.
Skills & Attributes:
In-depth knowledge of sterile injectable manufacturing processes
Strong understanding of USFDA, MHRA, and other regulatory requirements
Proven ability in managing large-scale aseptic production environments
Familiarity with QMS, validation, and cleanroom management
Strong leadership, communication, and team management skills
Attention to detail and a high commitment to quality and compliance
Estimated Salary: ₹45 – ₹65 LPA (depending on product complexity, automation level, and site scale)
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