Assistant Manager / Deputy Manager - Analytical Quality Assurance

Acme Generics Pvt. Ltd.; Solan; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Acme Generics Pvt. Ltd. in Solan, Himachal Pradesh, seeks a QA professional to manage Analytical Quality Assurance activities in QC. You will review and approve QMS documents, act as SPOC for submission activities, and ensure compliance with GDP/GLP.

You will oversee stability data review, logbooks, deviations, change controls, and batch release in ERP, while ensuring audit readiness and safety compliance.

Job description

Key Responsibilities:

• Manage all Analytical Quality Assurance (AQA) activities.
• Review, approve, and close Quality Management System documents related to QC.
• Act as Single Point of Contact (SPOC) for submission activities Dossier, Regulatory, Variation filings.
• Handle customer communications related to QA.
• Review manufacturing, packing, analytical reports of submission/validation batches.
• Review Stability data and ensure submission compliance.
• Ensure compliance of Stability Studies and Control Sample Handling at site.
• Ensure adherence to GDP/GLP.
• Monitor compliance of Gowning/De-gowning in QC lab.
• Authorize written procedures, amendments, and related documentation.
• Ensure SOP compliance across QC sections - RM/PM, FG, IP, AMV, PV, Stability, Tech Transfers, Microbiology, etc.
• Verify real-time documentation and analytical logs.
• Ensure logbooks and QC documentation are compliant and up-to-date.
• Manage and ensure compliance of Quality Agreements.
• Review and approve OOS/OOT, deviations, incidents, change controls.
• Ensure QC lab is audit-ready at all times.
• Oversee calibration, validation, maintenance, and qualification schedules.
• Responsible for Finished Goods (FG) batch release in ERP.
• Report and track safety near-misses/unsafe conditions.
• Participate in EHS trainings and safety events.