Description
JOB DESCRIPTION
This role involves performing complex routine and non-routine analytical testing on various pharmaceutical materials and products using a wide range of analytical techniques (Simple: HPLC, UPLC, GC, Dissolution, UV-Vis, FT-IR, Karl Fischer etc. and Sophisticated: LCMS, GCMS, XRPD, ICP-MS). Key responsibilities include independently performing method verification, transfer, and validation, conducting stability studies, and operating, maintaining, calibrating, and troubleshooting analytical instrumentation, including sophisticated equipment.The role requires meticulous documentation following GDP and ALCOA principles, preparing reports and Certificates of Analysis, and managing laboratory samples according to SOPs. A strong emphasis is placed on quality and compliance, strictly adhering to cGMP, GLP, and company procedures, identifying and investigating OOS/OOT/atypical results, and implementing CAPAs.The role will also be responsible for laboratory maintenance, safety protocols, waste disposal, equipment calibration, and inventory management. Additionally, the role involves continuous improvement activities such as training junior analysts, providing feedback on methods, staying updated with regulations, and participating in training programs.
Essential Functions
- Perform routine and non-routine testing of pharmaceutical samples using techniques such as HPLC, GC, and LC-MS, while supporting method validation and troubleshooting.
- Operate, calibrate, and maintain analytical instruments, ensuring proper functionality and assisting with equipment qualifications.
- Accurately record test data in compliance with GDP and ALCOA principles, and prepare reports, CoAs, and related documentation
- Manage sampling, logging, storage, and disposal of materials, including stability sample activities as per protocols
- Ensure compliance with cGMP, GLP, and SOPs/ promptly reporting any OOS, OOT deviations and laboratory incidents/ supporting investigations & CAPA actions
- Maintain a clean and safe laboratory environment, handle chemicals responsibly, and monitor equipment and inventory
- Mentor junior analysts, contribute to process improvements, stay current with regulatory updates, and participate in training programs.
Additional Responsibilities
- To ensure destruction of solid and liquid samples which are unused/ left over after analysis. Co-ordination with other departments for sending samples for outside laboratory testing.
- Responsible for the analysis & documentation of Raw-materials and packaging materials.
- Responsible and participate to perform the investigation for Quality issues like OOS, OOAL, Incident and deviations during laboratory activities.
- Responsible for the preparation and standardization of volumetric solutions/reagents and to maintain related documents adequately.
- Responsible for the preparation, handling & management of working/reference standards.
- Responsible for the preparation of SOPs and laboratory related documents.
- To ensure that documentation is done contemporaneously and in the legible manner.
- Responsible to perform analytical method transfer and analytical method verification of Raw material. Management & planning of samples to be analysed in quality control laboratory.
- Responsible to supervise quality control laboratory activity.
- Any other activities/tasks assigned by HOD
Education
QUALIFICATIONS
- Bachelors Degree (BA/BS) B. Sc. - Required
- Bachelors Degree (BA/BS) B. Pharm - Preferred
- Master Degree (MS/MA) M. Sc. - Preferred
- Master Degree (MS/MA) M. Pharm - Preferred
Experience
- 6 years or more in 6-12 years
Skills
- Analytical testing expertise and evaluation skills - Advanced
- Handling of simple analytical Instruments and Interpretation of Resulting Data - Advanced
- Handling of sofisticated analytical Instruments and Interpretation of Resulting Data - Advanced
- Laboratory Instrument qualification, Calibration & Maintenance - Advanced
- Quality Control & Compliance - Advanced
- Documentation & Data Integrity - Advanced
- Troubleshooting & Problem-Solving - Proficient
- LIMS Operation & Data Management - Advanced
- QMS Documentation (OOS, OOT, Incident) - Proficient
- Stability Study Documentation - Proficient
- Method Validation & Verification - Proficient
- Knowledge of Regulatory Guidelines - Proficient
- Good Manufacturing Practices (GMP) & Good Laboratory Practices (GLP) Knowledge - Proficient
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.
