Job Title:

Executive Production (QMS) Injectables

Core Objective: To oversee and implement Positive Manufacturing Practices (GMP) and Quality Management Systems (QMS) across sterile manufacturing areas, ensuring zero-defect batch processing, strict adherence to standard operating procedures, and audit readiness.

Key Responsibilities :

1. Documentation & Master Data Management

- Review master documents: Prepare and review Batch Manufacturing Records (BMR), Batch Production Records (BPR), and master SOPs for sterile parenteral facilities.
- Compliance verification: Ensure logbooks, line clearance records, and process orders are maintained without data integrity gaps.

2. Deviation & Incident Management

- Root cause analysis: Lead investigations into process-related deviations on the shop floor (e.g., environmental monitoring breaches, sterility assurance issues).
- Incident reporting: Draft comprehensive deviation reports and execute necessary risk assessments.

3. CAPA & Change Control

- Corrective and Preventive Actions (CAPA): Develop, implement,



and track effectiveness checks for CAPA plans to prevent the recurrence of quality incidents.

- Change management: Handle change controls for equipment modifications, process adjustments, or document updates while maintaining regulatory compliance.

4. Shop Floor Compliance & Audits

- Audit readiness: Assist in internal audits and face regulatory inspections (FDA, EMA, WHO-GMP) by ensuring operators follow aseptic behaviors and gowning procedures.
- Floor control: Ensure compliance with line clearance, sterilization records, and in-process quality assurance (IPQA) checks.

5. Training & Development

- GMP training: Coordinate and conduct routine cGMP, SOP, and contamination control training for operators and technicians using Learning Management Systems

Note : Only Male can Apply

Who are working in Injectable , Sterile Plant only should apply

For more Details Contact:

Sushanth Reddy - (phone hidden)

Kindly share your updated resume to: [email protected] or (phone hidden)

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