JOB DESCRIPTION

DESIGNATION : Dy. Gen. Manager–Q.C

REPORTING TO : Senior Vice President - Quality

1. AUTHORITIES:

1.1. To release or reject all raw materials and packing materials.

1.2. To release or reject all Active Pharmaceuticals Ingredients.

1.3. To certify all batches as per pharmacopieal or in-house specifications.

1.4. To sign gate pass of all material of Quality department going out of the factory
premises on returnable basis.

1.5. To approve leave of all employees reporting to you.

1.6. To approve all Q.A. related documents on behalf of Senior Vice President – Quality
in his absence.

2. RESPONSIBILITIES:
2.1. To forecast, plan, control and review expenditure involved in cost of Q.C. and
provide M.I.S. incase of deviation from budget.

2.2. To provide training on current regulatory guidelines (ICH) and instrumental analysis.

2.3. To ensure that samples of products, with technical data, is sent to Marketing for
development of business.

2.4. To ensure timely release of test results of materials received for testing as per the
agreements with the department concerned.

2.5. Release or reject RM’s intermediates, packing and labeling materials as per
specifications.

2.6. To ensure that instrument are periodically calibrated and maintained as per respective
SOP.

2.7. To prepare & update SOP’s to comply with ICH guidelines for the Quality Control
department.

2.8. To ensure that appropriate primary and secondary reference standards of API’s
produced are handled and used in accordance with written procedures.
JOB DESCRIPTION

2.9. To make sure that all Raw Materials used for manufacturing are from approved
sources.

2.10. To make sure that specification, sampling plans, and test procedures should be
scientifically sound and appropriate to ensure that raw materials, intermediates,
API’s and labels and packing materials conform to established standards of
quality and / or purity.

2.11. To provide inputs during preparation of DMF/ Vendor Questionnaire and on

deficiency letter received from regulatory bodies as and when required by
Regulatory Bodies.

2.12. To handle out-of-specifications (O.O.S) as per SOP and inform Q.A.

2.13. To ensure that reagents and standard solutions are prepared and labeled as per
SOP.

2.14. To make sure appropriate specifications are established for API’s, in accordance
with accepted standards and consistent with the manufacturing process / DMF
filing. The specifications should also include control of impurities.

2.15. To make sure that COA is issued for each batch of API or intermediate.

2.16. To make sure that a documented, on-going testing program is designed to

monitor the stability characteristics of API’s to confirm appropriate storage
conditions and retest for expiry dates as per ICH guidelines.

2.17. To make sure that retention samples are stored as per ICH guidelines.

2.18. To review product dossiers (D.M.F.) before submissions to regulatory

authorities as per C.T.D. Format.

2.19. To review impurity profile of API / intermediates periodically for comparison

against impurity profile in DMF filing, against historical data, and highlighting
the same.

2.20. To make sure that validated protocols and reports are approved by QA, prior to
use of the laboratory instruments.

2.21. To make sure that analysis of critical intermediates, API’s, API’s kept for stability;
cleaning procedures are by validated analytical methods.

2.22. To ensure that analytical methods are validated as per needs of regulatory bodies.

2.23. To make sure that analytical method, RM specifications, in-process control specs
received from R&D, are implemented in a correct way.
JOB DESCRIPTION

2.24. To ensure that sufficient stock of impurities are available with the department for
needs of customer by providing indents on time to process improvement &
development.

2.25. To justify CAPEX requirements and negotiate with laboratory equipments

suppliers as per directions of Senior Vice President - Quality.

2.26. To continuously drive improvements to refine, simplify analytical methods for

cost cutting and quality control purpose.

2.27. To provide analytical method development support to process improvement group

at the location as and when needed.

2.28. To ensure that each department staff and oneself clock minimum 52 hours of
training per year on various aspects of management, competency and skill
development areas as per training need analysis.

2.29. To carryout periodic appraisal of the group personnel for their merit rating and
participate in the recruitment, selection training and development of employees of
the department including preparation of job description.

2.30. To be responsive on tasks / assignments given, and be proactive in alerting the

concerned people, in advance, of the likely delay with its reasons.

2.31. To ensure maintenance of record of Books, Files, Registers, Floppies, etc.

depending upon usage. List of such filing / records shall be prepared in order of
convenient identification. To give instructions to all staff to be highly proficient in
maintaining them up to date.

2.32. As Deputy General Manager – Quality Control, carry out such jobs and other
connected or incidental jobs, which are necessary due to exigencies of companies
work and business requirements. Also to carry out such jobs that is within
capabilities and / or work in any other post which may be temporarily assigned.

SENIOR VICE PRESIDENT - QUALITY

Received: ___________________

Date : ___________________