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Ipqc Analyst

3-6 years
Not Disclosed
10 Jan. 30, 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: IPQC Analyst

Job Location: Bangalore
Department: Manufacturing
Reporting To: Manufacturing Lead
Job Grade: Senior Executive
Experience Required: 3-6 years


About Syngene

Syngene International Ltd. (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization (CRDMO) offering integrated scientific services from early discovery to commercial supply. Syngene prioritizes safety, operational excellence, and regulatory compliance in all its operations.

Commitment to Safety & Compliance

All employees at Syngene must:

  • Follow safety guidelines, SOPs, and regulatory procedures.
  • Maintain environment, health, and safety (EHS) compliance in all operations.
  • Complete mandatory training on data integrity, health, and safety within the assigned timeline.
  • Ensure compliance with Syngene’s quality standards at all times.
  • Be accountable for achieving safety goals and support audit readiness.

Job Purpose

The IPQC Analyst will be responsible for conducting in-process quality control (IPQC) analysis and raw material testing to support manufacturing activities. The role involves shift-based operations, calibration of instruments, documentation, and compliance with regulatory standards.


Key Responsibilities

Quality Control & Analytical Activities

  • Perform in-process and raw material analysis to ensure timely product release.
  • Conduct instrument calibration and maintenance for quality assurance.
  • Operate and maintain analytical instruments, including:
    • HPLC (High-Performance Liquid Chromatography)
    • SoloVPE (Variable Pathlength Extension System)
    • UV Spectrophotometry
    • Capillary Electrophoresis (CE)
    • iCE (Imaged Capillary Electrophoresis)

Documentation & Compliance

  • Prepare and maintain Standard Operating Procedures (SOPs), IOPs, and EOPs.
  • Support Computer System Validation (CSV) activities in the laboratory.
  • Ensure adherence to Good Laboratory Practices (GLP) and quality management systems (QMS).
  • Handle laboratory incidents, out-of-specification (OOS) cases, out-of-trend (OOT) results, and deviations.
  • Maintain audit readiness and participate in audit preparations.
  • Ensure completion of Corrective and Preventive Actions (CAPAs) from previous audits.

Process Improvement & Team Collaboration

  • Assist in shift management and coordination with the manufacturing team.
  • Ensure timely execution of assigned training and support team deliverables.
  • Work collaboratively to improve analytical efficiency and error-free documentation.
  • Coordinate with external vendors for calibration and preventive maintenance (PM) activities.

Leadership & Behavioral Competencies

  • Continuous Learning & Process Improvement
  • Accountability & Integrity in work execution
  • Collaboration within teams and cross-functional departments
  • Assertiveness & task ownership while maintaining professional conduct
  • Commitment to excellence and quality standards

Educational Qualification

  • M.Sc. in Biotechnology or Chemistry

Skills & Technical Capabilities

  • Analytical skills in IPQC and raw material testing
  • Shift operations management
  • Proficiency in Quality Management Systems (QMS)
  • Hands-on experience with analytical instrumentation

Equal Opportunity Employer

Syngene is an Equal Employment Opportunity (EEO) employer, ensuring fair opportunities for all individuals regardless of age, gender, nationality, race, religion, disability, or other protected characteristics. Reasonable accommodations are available for qualified individuals with disabilities.