Head of Production

1 week ago

Mumbai, Maharashtra, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full time

Profile : Production Head

Experience: 15 to 19 years of experience in pharma API pharma

Salary: 15 lpa

Location: Sandhurst Road Mumbai - Head office

RESPONSIBILITIES:

  1. Responsible for reviewing, approving and distributing work instruction for manufacturing activities.
  2. Carry out production activities as per production plan.
  3. Responsible to decide new batch production.
  4. Responsible for monitoring batch process. Review online documentation related to production activities like BMR, BPRs, logbooks and daily records.
  5. Qualification of production equipments and participation in validation activities.
  6. To check quality system in production department.
  7. To prepare equipment master list and equipment qualification plan.
  8. Review of MFRs, BMRs, BPRs, SOPs and formats.
  9. Review URS, DQ, IQ, OQ, PQ protocol with reports and validation protocol with reports.
  10. To ensure that all production deviations are reported, evaluated and that critical deviations are investigated, and the conclusions are recorded.
  11. Evaluation and investigation of all market complaints and necessary corrective and preventive actions jointly with QA.
  12. Initiating any change by originating change control request and to evaluate proposed changes in product, process or equipment.
  13. Review proper segregation of material, labeling and identification, area cleaning and disinfection.
  14. Review Preventive maintenance and calibration done according to schedule of equipments/ utilities and recorded.
  15. Check on production yields and reconciliation at various stages of manufacturing.
  16. Responsible for giving training to the personnel working in the production area.
  17. Responsible for handling of manpower and proper allocation of manpower.
  18. Responsible for Internal audit preparation.
  19. Participate in external audit preparation and handling activities during audit.
  20. To comply the requirements of technical audit.
  21. cGMP documentation and their revision as and when required.
  22. Identifying need and procurement of new machines and equipments.
  23. Resource identification (up gradation of existing equipments and manpower).
  24. Shift scheduling and sanctioning of production personnel.
  25. To comply the requirements of safety audit.
  26. Interaction with warehouse / quality control for material availability / release of raw material and packaging material, semi-finished and finished good.
  27. Co-ordination with engineering for maintenance / machine breakdown/ Modification.
  28. Control on scrap going out of department.
  29. To assure batch uniformity and integrity of drug products through written procedure followed by in process controls and tests of each batch.
  30. To monitor outputs and to validate the performance of manufacturing process.
  31. Periodical review of SOP related to production functions and inform QA to incorporate revisions for betterment of work/developments.
  32. Responsible to raise the deviation and change related issues to intimation the QA department.
  33. Responsible to participate in investigation and preparation of CAPA.
  34. To verify the function and performance of equipments/ utilities.
  35. To check and verify labeling and packing activity.
  36. Effectively Participate in re-processing and reworking activity.
  37. To check and verify the gowning, usage of PPE's in processing and controlled area.
  38. Compliance with cGMP norms.
  39. To ensure that all decisions, rules and policies related to environmental management system is followed.
  40. Investigation and CAPA implementation for environment related incident/deviation.

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