Assistant Manager - Audit & Compliance

Experience: 9-13 Years

Qualification- B.Pharma/M.Pharma

- Audit Execution: Plan, schedule, and conduct internal quality, process, and compliance audits across manufacturing plant sites.
- Regulatory Readiness: Support and coordinate external regulatory, statutory, and customer audits or inspections
- Lead investigations for compliance incidents, deviations, and audit findings, driving the implementation of Corrective and Preventive Actions (CAPA)
- Ensure adherence to Standard Operating Procedures (SOPs), Positive Manufacturing Practices (GMP), and internal control frameworks
- Identify operational or regulatory risks, review compliance data/analytics, and report findings to senior management
- Review quality management systems (QMS), logs, and documentation to maintain continuous audit readiness

Executive/Sr. Executive- Aseptic Operation Experience: 6-9 Years

Qualification- B.Pharma/M.Pharma

- Supervision of day-to-day operations in the aseptic area (filling line, filtration, sterilization, and support areas.
- Batch Execution & Documentation:
- Execute batches as per approved BMR.
- Ensure logbooks, checklists, and documents are online.
- Monitor and control critical manufacturing steps to ensure product quality.
- Aseptic Assurance Activities:
- Execution and participation in media fill (APS), smoke study, and environmental monitoring support.
- Preparation of media fill report and smoke study report.
- Equipment & Area Management:
- Ensure availability of sterilized components, media, disinfectants, and materials.
- Ensure readiness and cleanliness of area, equipment, and utilities
- Participate in qualification activities of the DP-manufacturing area,



including support for equipment and area qualification.

Officer- Autoclave Experience: 2-5 Years

Qualification- B.Pharma/M.Pharma

Responsibilities

- Execution of day-to-day operations in autoclave and manufacturing area (Autoclave, Batch Manufacturing, Disinfectant Preparation and Debagging areas).
- Execute batches as per approved BMR.
- Perform online documentation of logbooks, checklists, and BMR.
- Maintain accurate logbooks, cleaning records, and qualification documentation in line with GDP requirements.
- Aseptic Assurance Activities:
- Participate and support Media Fill (Process Simulation) operations as per defined protocol.
- Participate and support Smoke Study (Air Flow Visualization Test) during qualification and re-qualification activities.
- Perform line clearance of area and equipment during routine batch operation.

Technician- Aseptic Operation Experience: 02-08 Years

Qulaification: ITI/Diploma (Mechanical/Chemical)

- Aseptic Shop-Floor Management
- Operate aseptic area equipment such as Filling machine, Capping machine,Tray loader, FIT, BIT and Filtration vessel.
- Perform activities such as filtration, aseptic connections, and handling of sterile product and critical components.
- Participation in media fill (APS), smoke study, and environmental monitoring.
- Batch Execution & Documentation:
- Perform Aseptic assembly, aseptic filling and aseptic interventions as per defined procedure.
- Maintain accurate logbooks, cleaning records, and qualification documentation in line with GDP requirements.
- Equipment & Area Management:
- Carry out area cleaning and equipment cleaning as per approved SOPs and schedules.

Please share your CV at [email protected] / [email protected]

📌 Walk-in || Technician/ Officer/Sr. Executive/AM For Drug Product Manufacturing (Dhar)
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