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Senior Manager Production Injectables

15+ years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Parenteral Manufacturing Area Head (Block-E)


JOB SUMMARY:

The Parenteral Manufacturing Area Head is responsible for overseeing the Vial Filling Line, PFS Filling Line, Infusion Bag Line, API Line, Autoclave Area, Aseptic Area, and Freeze Drying Area within the Parenteral Manufacturing area (Block-E). This role also includes handling equipment qualification/requalification activities and ensuring compliance with cGMP standards and regulations.


KEY RESPONSIBILITIES:

Documentation & Compliance:

  • Sign off on Parenteral GMP documents (as doer, reviewer, and approver).
  • Perform breakdown memo analysis and impact assessment.
  • Approve equipment and area cleaning/sanitization logs.
  • Maintain and ensure cGMP documentation for the area and equipment log books are up to date.

Qualification & Re-Qualification Activities:

  • Oversee equipment qualification and re-qualification in the Parenteral Manufacturing area (Block-E).
  • Ensure compliance with regulatory requirements during the qualification/requalification of equipment in Vial Filling Line, PFS Filling Line, Infusion Bag Line, and API Line.

Quality Management System (QMS):

  • Be responsible for the overall Quality Management System (QMS) activities for Parenteral Manufacturing.

Operational & Process Oversight:

  • Oversee day-to-day activities within the Vial Filling Line, PFS Filling Line, Infusion Bag Line, API Line, Autoclave Area, Aseptic Area, and Freeze Drying Area.
  • Ensure proper operation and adherence to procedures within the Parenteral Manufacturing area (Block-E).

Miscellaneous:

  • Perform any other job duties as assigned by the Department Head.

JOB REQUIREMENTS:

Educational Qualification:

  • Required: Bachelor’s Degree in Pharmacy (B Pharm)

Experience:

  • Minimum Experience: 15+ years of experience in Parenteral manufacturing, specifically in USFDA-approved sites.

Skills & Certifications:

  • Required Skills: Expertise in cGMP documentation, qualification/requalification of parenteral equipment, and familiarity with Parenteral Manufacturing processes.

If you have extensive experience in parenteral manufacturing with USFDA-approved sites and are looking for an opportunity to lead critical manufacturing areas, apply now to join our team!