Description
JOB DESCRIPTION
The role involves ensuring CGMP compliance and supervising Filling & sealing activities in manufacturing area. Additionally, the position requires reviewing and maintaining online documents.
Essential Functions
- Responsible for document management like BMRs, BPRs, master SOPs etc..
- Responsible for preparation & review of the master documents of production.
- Responsible to ensure UAF working in area.
- Responsible for the handling of change control, deviations, investigation & CAPA, etc. Responsible for line clearance activity before commencing the operations.
- Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment's.
- Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
- Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area. Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area.
- Responsible for monitoring all the activities related to General, Control & Aseptic area.
Additional Responsibilities
- Responsible to give training to all the subordinates, technicians, and operators of the department.
- Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Responsible for self-hygiene.
- Responsible to attend the training as per schedule and to ensure the training and work as per TNI.
- To follow the cGMP, Good Document Practice, and discipline in the department.
Education
QUALIFICATIONS
- Bachelors Degree B. Pharm - Preferred
- Master Degree (MS/MA) M. Pharm - Preferred
Experience
- 5 years or more in 5 - 8 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.
