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Quality Control Manager

Keywords / Skills : Quality Control, Quality Control Manager, Quality Control Executive, Senior Quality Control Officer

10 - 20 years
Posted: 2019-03-05

Manufacturing/ Engineering/ R&D
Quality Assurance/ Control
Posted On
5th Mar 2019
Job Description
Job Responsibility:

1. To carry out the Preparation of Working Standards based on reference Standards and maintain the records.

2. Preparation of specifications & Protocol of raw material, packing material, bulk and finished products.

3. To carry out analysis as per specification and Protocol of raw material, packing material, bulk and finished products within specified time limits. To approve or reject product as per analysis carried out.

4. To Prepare certificate of analysis based on test results.

5. To carryout calibration of instruments as per calibration plan & maintain the records.

6. To co-ordinate with QA, production and store departments.

7. To implement Good Laboratories Practice in the department.

8. To review and maintain the quality control records.

9. To supervise all the activities of Quality Control Department.

10. Follow up to external labs for passing of all raw material and finished products.

11. Ensure effective functioning of Q.C. Laboratory.

12. Suggest improvement in for system, equipment / Instrument , process and test method.

13. Motivate and training of subordinate and colleague to improve quality standard.

14. Insure the safety in Q.C. Laboratory.

15. Handling customer, FDA,WHO,GMP, third party and Vendor Audit.

16. Customer co – ordination and handling customer complaint.

17. Responsible for corrective and preventive action for customer complaint & other Non-compliances, deviations and out of specification(oos). Root cause analysis of above.

18. Informing any Non confirming of product to Management. Inform management about any method not available, instrument not working or any other problem. To resolve the same on immediate basis.

19. To carry out normalization, standardization of solutions for titrations, analysis etc and affix proper status label on the same within specified validity.

20. To ensure preventive maintenance or get into annual maintenance contract with specified parties for calibration and maintenance of equipment /instrument within specified time or contract period.

21. To take care of instruments/equipment and handle them with proper care and SOP.

22. To maintain logbooks and instruments/equipment/HPLC columns/GC columns etc.

23. To maintain the log sheets of chemicals/solutions along with opening dates and validity of use and maintain consumption records.

24. To maintain consumption records of sensitive chemicals like acetic anhydride.

25. To maintain log book of each chemists on daily basis.

26. Ensuring that there is no (NC) non compliance in any audits.

27. Training to Employee for SOPs and Quality management system, GMPs/,WHO standards.

28. Responsible for House Keeping of QC dept. and Inter dept. discipline

29. Evaluating and approving change control for the specification and test method.

30. Review of water systems and trending.

31. To store working standards/reference standard in refrigeration.

32. To maintain and record temperature conditions in QC.

33. To keep any spares as required.

34. To maintain safety of password in computer system and password is known to only specified persons. Periodic changing of password is required. To keep back of all data on computer on daily /weekly/monthly basis.

35. To see that no data are deleted. To keep all data confidential & no data are taken out of company or any unauthorized person or organization.

36. To send COA to dispatch dept./customers/customs as and when required.

37. To verify that analysis data/protocols/graphs/dilutions are properly and correctly carried out.

38. To ensure proper status label to chemicals/solutions and store them at proper place and temperature.

39. To calibrate glassware and maintain proper storage.

40. To reduce manpower turnover.

41. Responsible for storage of control sample and retain samples.

42. Responsible for analyst training.

43. Send reports on life time cycle of each column.

44. Check column efficiency as regular interval.

45. Responsible for stability study of new sample on annually.

46. To keep stock of chemicals/solutions so that analysis are carried out within specified time.

47. Ordering need to be done in 10 days advance. See that no dead stock is kept for chemicals and no unnecessary stock is ordered. Maintain stock of chemicals/solutions.

48. To monitor wastage’s attributable to plant handling and processing and initiate measure to minimize them.

49. Finding GAPs & protocol in SOPs of QC department and make correction thereof.

50. Co-ordinate /preparation of HIRA/AI, OCPs, SOPs, WIs pertaining to QC department.

51. Communicate and participant all employees for preparation Aspect Impact & HIRA register.

52. Review of the quality for new vendor for RM & PM.

53. Periodic Review & preparation of all RM, PM, In-process finished product specifications protocol.

54. Responsible for Management review meeting, targets & objective review status. To handle all concerned activity related to Management representative.

EHS Responsibility:

1. Establish, implement and maintain EHS/QMS management system pertaining to QC department.

2. To take initiatives and measures to improve EHS performance like unsafe act, unsafe condition and zero accident.

3. Promote continual improvement related to EHS/QMS management system.

4. To Contributing in organizing Events like world Environment Day, National safety day, EHS Activities

5. To Co-Ordinate in internal audits of EMS & OHSAS

6. To Maintain Audit documents and ensuring effective implementation of audit recommendation.

7. To prepare & implement Risk and Environmental assessment.

8. Read & understand Safety Manuals

9. To train & Aware about company emergency System, Chemical Handling,

Reports to be submitted:

1. Product received/analyzed result and time limit.-daily

Quality Deviation & failure report. –as & when

2. Internal audit reports as and when done.

3. Equipment/instrument breakdown report( effect analysis to be included)

4. Repeat analysis report - daily

Root cause analysis for reanalysis/retest.

5. Nonconformance and CAPA during external and internal audit.

6. Calibrations & Validation carried out and reporting.

7. Chemical consumption report- monthly.

8. Retest of RM and FG Report-monthly

9. Annual service contract calendar report-monthly

10. Calendar of calibration report

11. Waste generation report-daily

12. No analysis done by each chemist -Report

Key Result Areas:

1. Customer Complaint must be zero from any customer/product.

2. Zero deviation in Following GMP,WHO, Schedule M guidelines.

3. Zero deviation in testing & reporting.

4. Zero deviation in schedule of calibration, validation & standardization of solutions.

5. Zero deviation in schedule of working standards preparation.

6. Zero internal customer complaint.

7. Minimum 4 man days training per employee(of QC dept.) to be achieved per year.

8. 100% timely submission of reports on time

9. Overtime to be zero

10. Zero incident of information hiding of incident/mistake

11. At least 45 safety meetings need to attend in a year out of 52.

12. Give at least 5 new innovative ideas to increase productivity of department or cost saving

13. 100% safty compliance in department.

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