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Senior Manager Production Injectables

15+ years
Not Disclosed
10 June 28, 2025
Job Description
Job Type: Full Time Education: B.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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)