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Ipqa Team Member

4-8 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: IPQA Team Member

Job Location: Bangalore
Date: 21st January 2025
Years of Experience: 4-8 years
Education: Master’s in Life Sciences / B.Tech-Biotechnology
Pay Grade: Not specified


About Syngene

Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is a top priority, integrated into both personal and professional responsibilities. Safety is valued on par with business performance, ensuring strict adherence to safety guidelines, procedures, and standard operating protocols (SOPs).


Safety Expectations for All Roles

  • Adhere to safe practices and procedures for self and the team.
  • Contribute to developing procedures and systems ensuring safe operations and compliance with integrity and quality standards.
  • Promote a corporate culture of Environment, Health, and Safety (EHS).
  • Ensure compliance with EHS protocols at all times.
  • Complete mandatory training on data integrity, health, and safety on time.
  • Maintain Syngene’s quality standards at all times.
  • Take accountability for safety goals and conduct regular safety reviews.

Core Purpose of the Role

  • Ensure in-process quality assurance (IPQA) compliance during biological product manufacturing.
  • Maintain process integrity, audit readiness, and adherence to cGMP.

Key Responsibilities

1. IPQA & Manufacturing Process Compliance

  • Manage shift activities related to IPQA.
  • Provide line clearance for batch manufacturing activities.
  • Review batch manufacturing records for compliance.

2. Audit & Regulatory Compliance

  • Conduct audit trail reviews of cGxP computerized systems.
  • Ensure compliance with cGMP regulations.
  • Oversee warehouse (WH) activities, including material receipt, dispensing, and handling of rejected materials.

3. Equipment & Cell Bank Management

  • Manage cell banks used in manufacturing processes.
  • Understand process equipment handling and operating systems.

Skills & Competencies

  • Experience in Drug Substance (DS) manufacturing (upstream & downstream) for biological products (preferably monoclonal antibodies - mAbs).
  • Knowledge of line clearance processes in DS manufacturing.
  • Strong understanding of audit trail verification for GxP computerized systems.
  • Familiarity with warehouse operations such as material receipt and dispensing.
  • Basic understanding of cGMP regulations.

Syngene Core Values

All employees must consistently align with Syngene’s core values:
Excellence
Integrity
Professionalism


Equal Opportunity Employer

Syngene is an equal opportunity employer and prohibits discrimination based on age, gender, race, disability, religion, sexual orientation, marital status, or any legally protected characteristic. Reasonable accommodations will be provided for qualified individuals with disabilities.

This structured format ensures clarity, completeness, and professionalism in defining the IPQA Team Member role at Syngene. 🚀