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.
Education
QUALIFICATIONS
- B. Pharma - Required
- Master Degree M. Sc - Preferred
- Master Degree M. Pharma - Preferred
Experience
- 4 years or more in 4 - 6 Years
Skills
- Material Specifications Review - Intermediate
- Material Release and Compliance - Intermediate
- Non-Conformance Management (RM/PM) - Intermediate
- Sampling and Testing Procedures for RM/PM - Advanced
- Regulatory Compliance for RM/PM - Intermediate
- Sampling of Raw & Packaging Materials - Intermediate
- GLP Compliance & Documentation - Intermediate
- Documentation & Data Integrity - Intermediate
- CAPA, Deviation, and Change Control Management - Intermediate
- Specifications & Test Methods Documentation - Intermediate
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Specialized Knowledge: Licenses:
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
About The Team
The
Human Resources team
partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.