AM / DM - Quality Control

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 300,000 - 600,000; Full time

Job summary

Amneal Pharmaceuticals requires QA/QC professionals to manage GLP-regulated laboratory activities, including documentation, audits, and regulatory submissions. You will coordinate method transfer and stability testing, ensuring compliance across all QC processes.

The role emphasizes vendor qualification, change control, and collaboration with ARD for material specifications and testing, in a fast-paced pharmaceutical environment in India.

Qualifications

• Experience in GLP-compliant laboratory environments.
• Strong documentation and audit trail skills.
• Familiarity with vendor qualification and change control processes.
• Knowledge of regulatory submissions and QA/QC practices.

Responsibilities

• Oversee pharmacopoeial updation and regional notifications.
• Evaluate nitrosamine impurities and post-approval changes.
• Review and approve method transfer, verification, and stability protocols.
• Maintain GLP compliance and document SOPs and QC reports.
• Coordinate with ARD/QA for new material specifications and testing.

Skills

GLP Compliance

QA Documentation

Vendor Management

Regulatory Submissions

Education

Bachelor's degree in Pharmacy

M.Pharm

Tools

LIMS

QA Software

Job description

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

Assessment of Vendor notification

• 1.ANDA and Post approval regulatory submission
• 2.Regulatory submission of International, Latum and EU Market
• 3.Assessment of CFT Change control.
• 4.Initiation and assessment of Change control for post approval material/components and finished products
• 5.Review of specification and MOA (Excipients, finished products and packaging materials etc.)
• 6.Review of QRM, APQR, Hold time, process validation, cleaning validation protocol and reports
• 7.Arrangement of three lots for vendor qualification program and preparation of vendor qualification testing report.
• 8.Review of DDP/DHF and Miscellaneous protocols and reports.
• 9.Review Quality Control (QC) Standard Operating Procedures (SOPs).
• 10.Review instrument logbooks and raw data for raw materials, packing materials, miscellaneous materials, in-process samples, finished products, and water analysis.
• 11.Maintain workplace cleanliness and ensure compliance with Good Laboratory Practices (GLP).
• 12.Prepare study protocols related to laboratory activities.

Documentation

• 13.Prepare vendor qualification reports and comparison reports; summarize Amneal test results and vendor test reports.
• 14.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.
• 15.Prepare indents as per material and product requirements.
• 16.Review specifications for raw materials, packing materials, in-process samples, finished products, and stability protocols as required.