- Cleaning and Operation as per the latest SOP for All Equipment.
- Maintaining and managing all types of equipment including Change parts in sanitized condition and as per guidelines laid down in cGMP.
- Compliance with EHS
- To perform all work related to Packaging as per instructions of assigned officer/executive/supervisor following defined and approved procedures.
- Material handling as per approved procedure.
- To get the required training from supervisors for cGMP and concerned SOP for operation and cleaning.
- To perform work as assigned by superior or department head.
- Supervision of manufacturing, processing, packaging, and holding of the drug product as per define and approved procedures for stability batches and commercial batches.
- Maintaining the area and equipment in an orderly manner as per cGMP requirements in a good state of repair and sanitized condition.
- To perform online documentation with respect to departmental procedures as per good documentation.
- To impart training of operation and cleaning related SOP to all subordinates and operators.
- Co-ordination for IQ / OQ for any new equipment / system.
- To perform PQ for any new equipment/system.
- To follow all concern departmental SOPs for day to day operation and cleaning.
- To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record.
- Review, execution, and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports, and all relevant Documents.
- To follow all safety rules and departmental general instructions.
- To perform work other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
- The candidate with good communication and interpersonal skills, computer knowledge and exposure to cGMP/GLP Knowledge and understanding of regulatory requirement is essential (Preferred 21 CFR compliance)
Experience: 2-7 Yrs
Salary: 1,50,000 to 6,50,000 INR (CTC)