Production chemist documentation

3 weeks ago

Visakhapatnam, India Lywo Hyderabad Full time

We are looking for a meticulous Chemist Production to manage production documentation preparation and batch record review at Synnat Pharma Private Limited. As a key member of our API Manufacturing Unit, you will play a crucial role in ensuring seamless production processes and adherence to the highest quality standards. Your responsibilities will include verifying daily logbooks, reviewing online Batch Manufacturing Records, and managing all production-related documents, including Process Deviation Control Orders (PDCOs). You will also be responsible for raw material indenting, updating activities in our ERP system, and participating in preventive maintenance programs. This role requires close coordination with the Shift In-charge and other departments to effectively follow production plans and maintain cGMP compliance. You will contribute to both internal and external audits, ensuring our operations meet regulatory requirements. Your expertise will be vital in maintaining the integrity of our manufacturing processes and supporting our commitment to quality and efficiency. If you are passionate about pharmaceutical production and thrive in a collaborative environment, we encourage you to apply.

Responsibilities:

  1. Create and prepare documentation for production operations with proficiency in MS Word and Excel.

  2. Conduct thorough batch record reviews (BMRs, PDCOs, cleaning records) to ensure accuracy, completeness, and compliance with cGMP.

  3. Prepare, update, and maintain production-related documents and SOPs, ensuring traceability and audit readiness.

  4. Collaborate with QA to resolve discrepancies or deviations and implement corrective actions.

  5. Coordinate with the Shift In-charge to execute production plans and meet timelines.

  6. Indent raw materials, track consumption, and maintain accurate ERP entries for production activities.

  7. Monitor inventory levels, report shortages, and support dispatch documentation after batch completion.

  8. Support internal and external audits by providing required records and ensuring compliance with regulatory standards.

  9. Investigate process deviations, prepare reports, and assist in implementing CAPA.

  10. Participate in preventive maintenance scheduling and maintain equipment calibration/maintenance records.

  11. Coordinate with maintenance teams to address equipment malfunctions and ensure readiness.

  12. Conduct self-inspections of production areas to identify compliance gaps and propose improvements.

  13. Ensure safety, adherence to cGMP practices, and continuous improvement in production operations.

General Expectations and Past Experiences:

  • Experience in API manufacturing with focus on batch record review and documentation preperation accuracy.
  • Strong understanding of cGMP, PDCOs, and production documentation practices.
  • Proficiency in ERP production modules for material management and tracking.
  • Familiarity with preventive maintenance coordination and equipment validation.
  • Experience in supporting audits and implementing CAPA.
  • Strong analytical skills, attention to detail, and cross-functional collaboration.

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