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Associate Quality Assurance – Mqa Downstream

2-6 years
Not Disclosed
10 Nov. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Associate Quality Assurance – MQA Downstream
Location: Vizag, India
Employment Type: Full Time
Category: Quality Assurance and Control
Experience Required: 2 to 6 years in Pharmaceutical Quality Assurance, MQA, or Production


Position Overview

ThePharmaDaily.com is seeking an experienced Associate Quality Assurance – MQA Downstream for a leading global pharmaceutical manufacturer. The role functions as the primary on-floor quality contact for Terminal Sterilization, Visual Inspection, and Packaging operations, ensuring adherence to cGMP, regulatory expectations, and internal quality standards.

This description is fully SEO-optimized, GEO-targeted, and GPT-optimized to attract qualified global talent.


Key Responsibilities

  • Ensure ongoing cGMP compliance across Terminal Sterilization, Visual Inspection, and Packaging operations.

  • Maintain regulatory alignment and ensure manufacturing procedures meet internal and industry quality standards.

  • Review electronic batch records (eBR) and assess AMP exceptions with support from senior team members.

  • Review batch reports, equipment audit trails, and perform AQL sampling and inspection activities in VIDT.

  • Execute batch start-up and close-out activities, including sensor challenge tests, recipe review, and documentation compliance.

  • Conduct routine process checks and daily on-floor walkthroughs to identify and escalate operational or compliance issues.

  • Assist in equipment breakdown assessments to evaluate potential impacts on product quality and patient safety.

  • Review equipment alarms and contribute to quarterly alarm trend assessments.

  • Report non-compliance observations and support corrective actions under senior guidance.

  • Participate in troubleshooting, process simplification, and continuous improvement initiatives to enhance efficiency and reduce downtime.


Minimum Qualifications

  • B.Pharm, M.Pharm, or MSc in a relevant scientific discipline.

  • 2–6 years of experience in Manufacturing Quality Assurance, Quality Assurance, or Production within a pharmaceutical manufacturing environment.

  • Strong understanding of cGMP and Quality Management Systems.

  • Ability to work collaboratively across departments and within cross-functional teams.

  • Strong written and verbal communication skills.

  • Hands-on experience in sterile or packaging operations is preferred.


Work Model: On-Site, Vizag

The employer is an equal opportunity organization and adheres to all relevant employment regulations.