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Senior Manager Production Injectables

15+ years
Not Disclosed
10 Jan. 31, 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

📌 Senior Manager – Production (Injectables) | Parenteral Manufacturing Area | Company: [Name]

📍 Location: [Location]
💼 Company: [Company Name]
🕒 Experience: 15+ Years in USFDA Approved Sites

Role Overview

The Senior Manager – Production (Injectables) is responsible for overseeing critical production areas in Parenteral manufacturing, including the Vial Filling Line, PFS Filling Line, Infusion Bag Line, API Line, and other aseptic production areas such as Freeze Drying, Autoclave, and Qualification/Re-qualification activities. This role is pivotal in ensuring cGMP compliance, maintaining quality management systems, and overseeing qualification activities for critical equipment.

Key Responsibilities

Production Area Oversight: Manage production areas in Parenteral Manufacturing Area (Block-E), including equipment and line activities for Vial Filling, PFS Filling, Infusion Bags, and Freeze Drying.
GMP Documentation: Responsible for the review, approval, and signing of GMP documents (including equipment qualification and re-qualification, cleaning/sanitization logs, and breakdown memos).
Quality Management System (QMS): Ensure robust QMS activities, ensuring compliance with cGMP for equipment and area activities.
Qualification/Re-qualification: Oversee qualification and re-qualification processes for equipment and areas in Parenteral manufacturing, ensuring they meet regulatory standards.
Compliance: Ensure all cGMP documents related to the production area are up-to-date and compliant with regulatory standards.
Team Leadership: Provide oversight and leadership to the team involved in these critical manufacturing processes.
Ad-hoc Responsibilities: Perform any other duties as assigned by the Department Head.

Required Qualifications & Skills

🎓 Education:

  • B Pharm (Bachelor’s in Pharmacy).

💼 Experience:

  • 15+ years of experience in Parenteral Manufacturing, with significant experience in USFDA approved sites.
  • Proven expertise in managing production lines and qualification processes for Parenteral manufacturing areas.

Desired Skills

  • Strong understanding of cGMP standards and Parenteral production processes.
  • Experience in handling USFDA compliance and other regulatory requirements.
  • Leadership and Team Management skills.
  • Expertise in Quality Management Systems (QMS) and equipment qualification.

Work Conditions

  • Travel Estimate: [If applicable]
  • Full-time position based in [Location].

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