Description
The role involves ensuring CGMP compliance and supervising lyophilizer activities in manufacturing area. Additionally, the position requires reviewing and maintaining online documents.
Essential Functions
- To plan line wise activity as per production schedule.
- Person shall be responsible for operation and handling of the general area.
- To follow SOPs and minimize the deviations.
- To follow GMP, GDP, Data Integrity as per respective SOP.
- To work with the GMP and compliance in manufacturing process.
- To maintain cleanroom with define cleaning frequency.
- To Report if abnormality/Deviation observed to immediate supervisor.
- To complete the short term and long-term goals / objective as set by H.O.D
- To ensure timely execution of batch manufacturing plan.
- To control the rejection at various stages of manufacturing.
- To review and review document of all operations.
- To handle and monitoring and troubleshooting of Lyophilizer, ALUS, Autoclaves and general area activities.
Additional Responsibilities
- Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
- To perform aseptic behaviour/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.
Education
QUALIFICATIONS
- Bachelors Degree (BA/BS) B. Sc. - Required
- Bachelors Degree (BA/BS) B. Pharm - Required
- Master Degree (MS/MA) M. Sc. - Preferred
- Master Degree (MS/MA) M. Pharm - Preferred
Experience
- 3 years or more in 3 - 6 Yrs
Skills
- Good Manufacturing Practice - Proficient
- Batch Record Review - Proficient
- Document Review - Proficient
- Equipment and Process Validation - Proficient
- Deviation Management - Proficient
- Compliance and Regulatory Knowledge - Proficient
- Internal Audits and Inspections - Proficient
- cGMP and Compliance Review - Proficient
- Manufacturing Activity Supervision - Proficient
- IPQA Instrument Calibration - 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.
