Instagram
youtube
Facebook

Ipqa Team Member

4-8 years
Not Disclosed
10 Jan. 28, 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
Date: 21 Jan 2025
Job Location: Bangalore


About Syngene

Syngene International Ltd. is an innovation-driven contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the core of everything we do. Safety performance is aligned with business goals and is a shared responsibility at every level.


Core Purpose of the Role

The IPQA (In-Process Quality Assurance) Team Member will be responsible for handling in-process quality assurance activities, ensuring compliance with safety and quality standards in the manufacturing process of biological products. This role includes monitoring and reviewing batch records, conducting audits, and managing cell bank activities.


Key Responsibilities

In-Process Quality Assurance:

  • Handle shift activities of IPQA to ensure smooth operations in quality assurance.
  • Provide line clearance for batch manufacturing activities to ensure compliance with operational standards.
  • Review batch manufacturing records to verify that processes are conducted according to predefined protocols.
  • Manage cell bank processes and ensure proper documentation.
  • Perform audit trail reviews of cGxP (current Good Manufacturing Practice) computerized systems to ensure compliance.

Compliance & Safety:

  • Adhere to safety protocols, ensuring both personal and team safety at all times.
  • Participate in the continuous improvement of safety systems and processes.
  • Ensure compliance with Syngene’s quality standards and relevant cGMP (current Good Manufacturing Practice) regulations.

Specific Role Requirements

  • Experience: 4-8 years of experience in quality assurance, specifically in DS (Drug Substance) manufacturing, upstream and downstream processes in biological products (preferably monoclonal antibodies).
  • Skills:
    • Knowledge of line clearance processes in DS manufacturing.
    • Familiarity with audit trail verification of cGxP computerized systems.
    • Experience with process equipment handling and operating systems.
    • Understanding of warehouse activities such as material receipt, dispensing, and handling rejected materials.
    • Basic understanding of cGMP regulations and compliance.

Qualifications

  • Education: Master’s degree in Life Sciences or B.Tech in Biotechnology.

Syngene Values

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene is an equal opportunity employer committed to diversity and inclusion. We provide equal employment opportunities regardless of age, color, nationality, disability, race, religion, gender, sexual orientation, gender identity, marital status, or any other characteristic protected by law. Reasonable accommodations are available for qualified individuals with disabilities.

For more details, visit www.syngeneintl.com.