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Injectable Fill Finish (Qms And Mfg.)

11-15 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: Injectable Fill Finish Expert (QMS and Mfg.)

Date: 16 Jan 2025
Job Location: Bengaluru, India
Department: Formulation Production
Pay Grade: Not specified
Years of Experience: 11-15 years
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Company Overview

Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services, ranging from early discovery to commercial supply. Syngene places a strong emphasis on safety, ensuring it aligns with business performance by adhering to safety guidelines, procedures, and SOPs in all operations.


Core Purpose of the Role

Responsible for overseeing the Quality Systems (QMS) of Injectable formulation production activities, ensuring compliance with safety standards, operational excellence, and the achievement of production goals.


Key Responsibilities

  1. QMS Documentation Management:

    • Manage and ensure compliance with QMS documentation, including change control, deviations, investigations, OOS, OOT, customer complaints, validation protocols, CAPA, APQR, and audit management, both manually and electronically via EQMS.
  2. Support for Manufacturing & Packing:

    • Support the planning and coordination of manufacturing and packing activities for both small molecule formulations and large molecules (biologics) products, with a focus on aseptic filling and sealing.
  3. Cross-Functional Coordination:

    • Collaborate with various cross-functional departments to ensure timely completion of production targets and support achievement of weekly, monthly, and annual production goals.
  4. Facility Planning & Management:

    • Oversee facility planning to meet production targets, ensure capacity utilization, and monitor production activities. Ensure the smooth functioning of production for clinical and commercial batches. Approve purchase orders for instruments, equipment, and consumables required for daily operations.
  5. Compliance with cGMP & Regulatory Standards:

    • Implement current Good Manufacturing Practice (cGMP) requirements and ensure compliance with USFDA, EU, and MHRA standards. Support preparations for client visits and regulatory audits.
  6. Production Target Achievement:

    • Ensure monthly production targets are met by complying with established quality standards and safety protocols.

Education & Experience

  • Educational Qualifications:
    • Bachelor’s degree in Pharmacy or a Master’s degree in Pharmacy/Science.
  • Experience:
    • 11-15 years of relevant experience in injectable fill finish, QMS, and manufacturing operations.

Skills & Capabilities

  • Technical Skills:

    • Expertise in QMS documentation management (change control, deviations, investigations, etc.)
    • Knowledge of aseptic filling and sealing processes for injectable formulations.
    • Familiarity with regulatory compliance (USFDA, EU, MHRA) and cGMP requirements.
  • Behavioral Skills:

    • Strong team player with a result-oriented focus.
    • Excellent coordination skills for working across departments and achieving production targets.

Syngene Values

Syngene is committed to maintaining core values in all roles:

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene is an equal opportunity employer committed to diversity and inclusion. The company provides equal employment opportunity (EEO) to all individuals regardless of race, religion, gender, sexual orientation, disability, or other protected status by law. Syngene also offers reasonable accommodations for qualified individuals with disabilities.