Executive, Quality Control

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC invites applications for a QC Analyst role to perform qualitative and quantitative analysis of raw materials, in-process and finished products, ensuring compliance with pharmacopeial standards. The candidate will document results, maintain instruments, and support audits.

Experience with LIMS and GDP is desired. The role emphasizes adherence to cGMP/GLP, calibration of instruments, and collaboration with QA and Regulatory teams to ensure timely material release for

Qualifications

• Bachelors Degree B. Pharma required.
• Master Degree M. Sc preferred.
• Master Degree M. Pharma preferred.

Responsibilities

• Perform testing of raw materials, APIs, excipients, and packaging materials per approved specifications and pharmacopeial methods.
• Record results accurately in logbooks, worksheets, and LIMS per GDP.
• Adhere to cGMP, GLP, and safety protocols during sample handling and instrument usage.
• Perform qualification, calibration, and maintenance of lab instruments.
• Maintain calibration and qualification status of analytical equipment.
• Coordinate with QA for sampling of incoming materials per SOPs.
• Ensure proper labeling, storage, and disposal of samples and reference standards.
• Support audits by providing required documentation and clarifications and implement CAPA as per findings.
• Participate in method validation, verification, and transfer activities; assist SOP updates.

Education

Bachelor's Degree in B. Pharma

Master's Degree in M. Sc

Master's Degree in M. Pharma

Tools

LIMS

Job description

JOB DESCRIPTION

To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products.

Description

To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products.

Essential Functions

• Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc.).
• Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP).
• Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage.
• Performing qualification, periodic calibration, and maintenance of laboratory instruments.
• Maintain proper cleanliness, calibration, and qualification status of analytical instruments.
• Coordinate with warehouse and QA for sampling of incoming materials as per SOPs.
• Ensure proper labeling, storage, and disposal of samples and reference standards.
• Support internal, customer, and regulatory audits by providing required documentation and clarifications.
• Implement corrective and preventive actions (CAPA) as per audit observations.

Additional Responsibilities

• Participate in method validation, verification, and transfer activities as required.
• Assist in updating and reviewing SOPs, specifications, and analytical procedures.
• Contribute to continuous improvement initiatives in the QC department.
• Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor.
• Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.

QUALIFICATIONS

• Bachelors Degree (BA/BS) B. Pharma - Required
• Master Degree (MS/MA) M. Sc - Preferred
• Master Degree (MS/MA) M. Pharma - Preferred

Experience

• 4 years or more in 4 - 6 Years