Manager Quality Control

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Regulatory Affairs/Quality Assurance professional with expertise in pharmacopeial updates, nitrosamine risk assessment, and post-approval change management. The role involves review of audit trails, method transfers, stability oversight, and LIMS troubleshooting in a GMP environment.

The candidate will coordinate vendor qualification activities, review regulatory submissions across international markets, and ensure GLP compliance, SOPs, and QRM documentation

Responsibilities

• Pharmacopeial Updation and notification of updated to all India regions.
• Evaluation of Low molecules nitrosamine impurities and NDSRI of all commercial products
• Evaluation of post approval changes and assessment of Nitrosamine, Element impurities and residual solvent
• Review of justification of audit trail related with empower and other than empower software of QC and ARD.
• Preparation/Review of Method Transfer, Method Verification protocol and report in QC.
• Oversee stability samples as per approved stability protocols, including charging, retrieval, and documentation.
• Oversee the movement of stability samples related charging and withdrawal form stability chambers.
• Troubleshooting in LIMS.
• ANDA and Post approval regulatory submission
• Regulatory submission of International, Latam and EU Market
• Assessment of CFT Change control.
• Initiation and assessment of Change control for post approval material/components and finished products
• Review of specification and MOA (Excipients, finished products and packaging materials etc.)
• Review of QRM, APQR, Hold time, process validation, cleaning validation protocol and reports
• Arrangement of three lots for vendor qualification program and preparation of vendor qualification testing report.
• Review of DDP/DHF and Miscellaneous protocols and reports.
• Review Quality Control (QC) Standard Operating Procedures (SOPs).
• Review instrument logbooks and raw data for raw materials, packing materials, miscellaneous materials, in-process samples, finished products, and water analysis.
• Maintain workplace cleanliness and ensure compliance with Good Laboratory Practices (GLP).
• Prepare study protocols related to laboratory activities. Documentation
• Prepare vendor qualification reports and comparison reports; summarize Amneal test results and vendor test reports.
• Coordinate with the ARD department for new material specifications and methods of analysis for APIs, excipients, and packaging materials; prepare related specifications and methods of analysis.
• Prepare indents as per material and product requirements.
• Review specifications for raw materials, packing materials, in-process samples, finished products, and stability protocols as required.

Job description

Role & responsibilities

• Pharmacopeial Updation and notification of updated to all India regions.
• Evaluation of Low molecules nitrosamine impurities and NDSRI of all commercial products
• Evaluation of post approval changes and assessment of Nitrosamine, Element impurities and residual solvent
• Review of justification of audit trail related with empower and other than empower software of QC and ARD.
• Preparation/Review of Method Transfer, Method Verification protocol and report in QC.
• Oversee stability samples as per approved stability protocols, including charging, retrieval, and documentation.
• Oversee the movement of stability samples related charging and withdrawal form stability chambers.
• Troubleshooting in LIMS.

Assessment of Vendor notification

• ANDA and Post approval regulatory submission
• Regulatory submission of International, Latam and EU Market
• Assessment of CFT Change control.
• Initiation and assessment of Change control for post approval material/components and finished products
• Review of specification and MOA (Excipients, finished products and packaging materials etc.)
• Review of QRM, APQR, Hold time, process validation, cleaning validation protocol and reports
• Arrangement of three lots for vendor qualification program and preparation of vendor qualification testing report.
• Review of DDP/DHF and Miscellaneous protocols and reports.
• Review Quality Control (QC) Standard Operating Procedures (SOPs).
• Review instrument logbooks and raw data for raw materials, packing materials, miscellaneous materials, in-process samples, finished products, and water analysis.
• Maintain workplace cleanliness and ensure compliance with Good Laboratory Practices (GLP).
• Prepare study protocols related to laboratory activities. Documentation
• Prepare vendor qualification reports and comparison reports; summarize Amneal test results and vendor test reports.
• Coordinate with the ARD department for new material specifications and methods of analysis for APIs, excipients, and packaging materials; prepare related specifications and methods of analysis.
• Prepare indents as per material and product requirements.
• Review specifications for raw materials, packing materials, in-process samples, finished products, and stability protocols as required.