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Qa Controlled Docs Sr. Coordinator

2+ years
Not Disclosed
10 April 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: QA Controlled Docs Sr. Coordinator
Location: Bangalore & Mumbai
Category: Regulatory/Compliance
Job ID: 25903


Summary of Responsibilities:

  • Follow departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).

  • Complete all required trainings within set timelines.

  • Administer controlled documents to ensure availability for end users.

  • Track and report metrics as determined by management.

  • Assist in the implementation of new or revised processes and procedures.

  • Communicate effectively with internal stakeholders.

  • Perform quality checks on completed work.

  • Ensure timely escalation and resolution of issues affecting document release.

  • Adhere to Regulatory Compliance and Quality Assurance (RC and QA) responsibilities per applicable controlled documents.

  • Execute all other duties as assigned.


Qualifications (Minimum Required):

  • Minimum 2 years of experience in a regulatory environment, specifically in GXP roles.

  • Strong analytical skills and attention to detail.

  • Ability to plan, prioritize, organize, and communicate effectively.

  • Comfortable working extensively on a computer.