Instagram
youtube
Facebook

Qa Auditor -Bioanalytical

12-14 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: QA Auditor - Bioanalytical
Job Location: Bangalore
Date: 24 Jan 2025


About Syngene

Syngene International Ltd. (www.syngeneintl.com) is a leading innovation-driven contract research, development, and manufacturing organization offering integrated scientific services across early discovery to commercial supply. Syngene’s work culture emphasizes safety, integrity, and quality standards, fostering a strong commitment to environmental, health, and safety (EHS) compliance.


Core Purpose of the Role

The QA Auditor for Bioanalytical will be responsible for ensuring compliance with Quality Management Systems (QMS) in bioanalytical research laboratories, data management, biostatistics, and related departments. The role includes conducting audits, reviewing key documentation, managing SOPs, and driving continuous quality improvements aligned with regulatory guidelines and industry standards.


Key Responsibilities

Quality Management System (QMS):

  • Oversee and maintain the QMS for Bioanalytical Research Laboratory and related departments.
  • Manage the preparation, revision, and review of SOPs across relevant departments.
  • Initiate and review change controls, ensuring timely follow-up and closure.
  • Maintain and control QA department records.

Qualification & Validation:

  • Review qualification and validation documents for bioanalytical processes and equipment.

Audit Management:

  • Plan, execute, and document audits, including study-based audits, process audits, quality system audits, and vendor audits.
  • Prepare and review audit reports, corrective and preventive action plans, and follow up on closures.
  • Conduct retrospective audits by reviewing raw data chromatograms.

Document Review:

  • Review bioanalytical protocols, testing procedures, study plans, method validation reports, bioanalytical reports, and clinical study reports.
  • Verify pharmacokinetic (PK) and pharmacodynamic (PD) analysis data for accuracy and compliance.

Best Practices:

  • Share best practices and improvement ideas within the QA team.
  • Ensure adherence to GCP, GLP, 21 CFR, and other bioanalytical guidelines.

Role Accountabilities

  • Conduct protocol and SOP reviews related to bioequivalence.
  • Perform in-process audits during method validation and study sample analysis.
  • Review method validation, bioanalytical reports, and clinical study reports.
  • Ensure accurate review of pharmacokinetic and statistical analysis data.

Educational Qualification

  • M.Pharm or M.Sc. in a relevant field.

Experience & Skills

  • Experience: 12–14 years of experience as a bioanalytical QA professional.
  • Technical Skills:
    • Strong knowledge of QA, GCP, GLP, bioanalytical guidelines, and 21 CFR regulations.
    • Proficiency in pharmacokinetics (PK) and pharmacodynamics (PD).
    • Expertise in audit management and compliance protocols.

Syngene Values

All employees are expected to consistently align with Syngene’s core values:

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene provides equal employment opportunities (EEO) to all individuals regardless of age, gender, nationality, disability, or other protected characteristics. Reasonable accommodations are available for qualified individuals with disabilities.


For more details, visit Syngene’s official website.