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.
Gujarat :
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