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Vial/Pfs Filling Operator

3-6 years
Not Disclosed
10 Jan. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Vial/PFS Filling Operator
Job Location: Bengaluru, India
Date: 10 Jan 2025
Experience Required: 3-6 years


Company Overview:

Syngene International Ltd. is a leading contract research, development, and manufacturing organization, offering integrated scientific services from early discovery to commercial supply. The company is committed to maintaining the highest standards of safety, quality, and operational excellence in all aspects of its work.

Job Purpose:

The Vial/PFS Filling Operator is responsible for the quality systems related to injectable formulation production activities, focusing on the operation and maintenance of various manufacturing equipment for aseptic filling, sealing, and sterilization processes.

Key Responsibilities:

  • Aseptic Filling and Sealing Operations:

    • Operate vial filling machines, vial sealing machines, and filling isolators with VPHP generators.
    • Perform aseptic filling and sealing operations to ensure product quality and regulatory compliance.
  • Machine Setup and Maintenance:

    • Responsible for machine setup, operation, dismantling, and cleaning of manufacturing equipment such as vial/PFS filling machines, terminal sterilizers, and filtration vessels.
    • Operate and maintain lyophilizers, sterilizers, and other essential equipment, ensuring proper functioning and cleanliness.
  • Qualification and Testing:

    • Perform routine qualifications of equipment including vial/PFS filling machines, steam sterilizers, terminal sterilizers, and lyophilizers.
    • Operate leak testing machines and filter integrity testers.
    • Conduct visual inspections and oversee labeling operations to ensure product accuracy.
  • Compliance and Documentation:

    • Adhere to standard operating procedures (SOPs), critical operations procedures (COP), and process hold times (PHT) for manufacturing and filtration vessels.
    • Ensure compliance with safety guidelines, quality standards, and regulatory requirements.
    • Complete all necessary training related to data integrity, safety, and quality measures.
  • Team Collaboration:

    • Work closely with cross-functional teams to ensure smooth and efficient operations.
    • Contribute to maintaining a safe work environment and promoting a culture of continuous improvement.

Syngene Values:

  • Excellence
  • Integrity
  • Professionalism

Experience and Qualifications:

  • Experience:

    • 3 to 6 years of relevant experience in a sterile injectable pharmaceutical organization.
    • Hands-on experience with vial filling, sealing, and isolation systems.
  • Technical Skills:

    • Expertise in aseptic filling, sealing, and operation of vial/PFS filling machines and other manufacturing equipment.
    • Experience with equipment qualification, including leak testing and filter integrity testing.
    • Knowledge of equipment cleaning and sterilization processes (e.g., COP, PHT, CIP, SIP, VLT).
    • Familiarity with lyophilizer operations and qualification will be an added advantage.
  • Behavioral Skills:

    • Team-oriented, result-driven, and focused on operational excellence.
    • Ability to follow safety procedures and quality standards diligently.
  • Educational Qualifications:

    • Diploma or B.Sc in a relevant field.

Equal Opportunity Employer:

Syngene is an equal opportunity employer, committed to ensuring diversity and inclusion in the workplace. The company provides reasonable accommodations for individuals with disabilities and complies with all applicable equal employment laws.