Executive/Sr. Executive - Drug Product Manufacturing

Designation: Executive/Sr. Executive (Aseptic and QMS)

Department : Drug Product Manufacturing

Required Experience : 5-10 years

Job Location: Sec -3 , Pithampur, Dhar, M.P.

Executive/Sr. Executive - Aseptic

Role & responsibilities

• Supervision of day-to-day operations in the aseptic area (filling line, filtration, sterilization, and support areas.
• Execution and participation in media fill (APS), smoke study, and environmental monitoring support.
• Preparation of media fill report and smoke study report.
• Ensure availability of sterilized components, media, disinfectants, and materials.

Executive/Sr. Executive - QMS

Role & responsibilities

• Handle Change Control, Deviations, OOS/OOT, Investigations, and CAPA in the QMS system.
• Ensure compliance with cGMP, GDP, and data integrity requirements.
• Support timely closure of QMS events as per defined timelines.
• Prepare and review SOPs, BMR/BPR, protocols, and reports.
• Ensure accuracy, completeness, and traceability of all QMS documents.
• Handle electronic systems such as eBMR, TrackWise, EDMS, and eLogbook.
• Support preparation and execution of process validation and qualification activities.
• Coordinate with Production, QA, QC, and Engineering for QMS-related activities.
• Support technology transfer, scale-up, and new product introduction.

Please share resume at [email removed]