Sr. Manager

Profile Summary:

The QC – Sr. Manager has the responsibility of setting up and implementing Quality systems and strategies. The key responsibilities include Quality control personnel management, analytical method execution. In addition, he or she will make sure that quality risks are correctly assessed, identified and managed for all production activities and product development procedures to meet customer expectations.

Expected Qualification

A Bachelor’s or Master’s degree in chemistry.

Expected number of years of experience.

12+ years of Experience.

Roles and Responsibilities:

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 for system, equipment / Instrument, process and test method.
13. Motivate and training of subordinate and colleagues to improve quality standard.
14. Ensure 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 chemist on daily basis.
26. Ensuring that there is no (NC) noncompliance 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 at regular interval.
45. Responsible for stability study of new sample on annually.
46. To keep stock of chemicals/solutions so that analysis is carried out within specified time.
47. Finding GAPs & protocol in SOPs of QC department and make correction thereof.
48. Co-ordinate /preparation of HIRA/AI (aspect, Impacts), OCP (Operation control procedure) s, SOPs, WIs pertaining to QC department.
49. Review of the quality for new vendor for RM & PM.
50. Periodic Review & preparation of all RM, PM, In-process finished product specifications protocol.

Skills Required

• A good understanding of analytical testing and equipment operation / troubleshooting
• Knowledge and understanding of analytical methodologies and instrumentation.
• Possession of good communication, troubleshooting and function skills.
• Proactive attitude towards work and learning new techniques.
• Good time management skills.
• Good organizational skills.
• Ability to work in a team.
• Ability to communicate clearly and concisely in English, both orally and in writing
• Computer programs and applications.
• Mathematical and statistical skills.