Associate Manager - BQ QMS & Compliance

Jobtailor; Visakhapatnam; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Jobtailor is seeking a highly skilled professional for leading laboratory investigations within the pharmaceutical quality domain. You will handle LIR/RAAC/Incident and QAR investigations, ensure data accuracy, and drive CAPA through the eQMS.

Collaboration with cross-functional teams is essential to close actions on time. The ideal candidate holds an MSc in Microbiology or an equivalent qualification with extensive experience in microbiological testing, QA operations, and compliance with

Qualifications

• M.Sc in Microbiology or associate degree with 8+ years in pharma QA
• Strong technical skills in method validation and testing
• Experience in microbiological testing of pharmaceutical industry
• Deep understanding of pharmaceutical manufacturing, packaging, and QA operations
• Detail-oriented with robust knowledge of quality systems
• Familiarity with research unit clinical and analytical laboratory environments
• Effective written and verbal communication and interpersonal skills

Responsibilities

• Investigate quality issues from laboratory investigations
• Conduct deviation, out-of-specification and atypical result investigations
• Review protocols, analytical results and documents related to investigations
• Perform LIR/RAAC/Incident and QAR through eQMS
• Initiate corrective and preventive actions related to LIR/RAAC/QAR
• Ensure on-time submissions for closure of investigations
• Prepare Annual Trend for Laboratory Investigations
• Ensure accuracy of analytical data prior to closure
• Coordinate with cross-functional teams for closure
• Track and close action items on time

Skills

Method validation

Microbiology testing

Quality systems knowledge

Written & verbal communication

Interpersonal skills

GxP / QA operations understanding

Education

M.Sc in Microbiology

Associate degree in a relevant field

Tools

eQMS

Job description

Responsibilities

• Accountable for investigation of quality issues related to Laboratory investigations
• Responsible for deviation investigation and out-of-specification and atypical result investigation
• Reviews protocols, analytical results and/or documents associated with investigations
• Conduct laboratory investigations (LIR/RAAC/Incident and QAR) through eQMS
• Initiate corrective and preventive actions related to LIR/RAAC/QAR
• On‑time submissions of LIR/RAAC/incident and QAR for closure
• Prepare Annual Trend for Laboratory Investigations
• Ensure accuracy of analytical data prior to closure of investigations
• Coordinate with CFTs for closure of investigations
• Track and close action items on time

Requirements

• M.Sc in Microbiology or associate degree with minimum 8+ years of experience with relevant experience
• Strong technical skills in method validation and testing
• Experience in microbiological testing of pharmaceutical industry
• Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
• Detail‑oriented with robust knowledge of quality systems
• Familiarity with research unit clinical and analytical laboratory environments
• Effective written and verbal communication, as well as interpersonal skills

Core Competencies

Demonstrates expertise in laboratory investigations, including deviation and out‑of‑specification investigations, while ensuring compliance with quality systems and effective communication with cross‑functional teams. Proficient in method validation and microbiological testing within the pharmaceutical industry.