Description
JOB DESCRIPTION
- To perform / review daily calibration of laboratory equipment, lamp energy check, time synchronization check, temperature monitoring and any compliance related activities.
- To maintain laboratory equipment in proper operating condition and perform calibration as required, after completion allied training of sophisticated instruments i.e. UPLC, HPLC, GC, ICP-OES, ICP-MS, Dissolution Apparatus etc.
- To deliver consistent and precise results by following safety and GXP protocols/ SOPs/ regulatory guidance.
- To associate service/instrument engineer during routine preventive maintenance and troubleshooting/repair services on all laboratory equipment.
- To establish, execute and evaluate laboratory instrument calibration procedures and policies.
- To prepare qualification protocol / report and compliance documents.
- To prepare and execute the Computer Systems Validation protocols and to make sure that all GxP computer-based systems are operating as intended and meet regulatory requirements.
- To interact with Quality Assurance and service providers, other cross functional department related to CSV, Qualification and PM activity.
- To prepare / revise Standard Operating Procedures, through change control procedure in accordance to regulatory guidance / reference documents.
- To update lab compliance documentation system to exceed good laboratory practice, nearly meeting site GXP quality standard expectations.
- To create, update, review and manage of Calibration, Preventive maintenance, and validation schedule.
- To review Third-Party Documents / Certificate of Analysis.
- To receive and manage controlled issued documents from QA Department.
- Issuance of Laboratory notebook, Equipment logbook and Column usage registers.
- To qualify in-house Working / Reference standard and impurities.
Essential Functions
- Calibration and Qualification of various instruments.
Additional Responsibilities: To assist for CSV activity with senior scientist
Education
QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience
- 5 years or more in 5 - 8 Years
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.
