Senior Manager - Quality Control

Roles and Responsibilities

1.      To manage QMS activity like change control, Deviation, CAPA, OOS, OOT, Lab

events etc.

2.      To Conduct Risk Assessment& SOP reviews; investigating& supporting in the grievances.

3.      Responsible for Document & review Specification, SOPs, Review of Test Data Sheet, Analytical

Test Report & Masters.

4.      Responsible for review of Method Validation Protocols & Method Validation Reports.

5.      To Monitor the Review of calibration/Preventive maintenance schedule.

6.      Responsibilities to Initiate for Procurement of impurity standard/reference standard,

chemicals/reagents, columns, Laboratory glasswares etc.

7.      To Develop and implement Site Policies & Procedures (SOPs) to assure compliance with

regulatory requirements, and corporate policies

8.      Responsibilities to Supervising deviation review and managing the CAPA review, approval and

implementation reviews

9.      To Create goals, objectives and measures to drive continuous improvement of the QC operations

10.  To ensure system and procedures are in place for the data integrity. Carryout frequent checks and

challenge tests to maintain compliance and consistency in data security, storage, archival,

verification & originality.

11.  Responsible for leading root cause investigations.

12.  Responsible for preparation of experiment plan during investigation.

13.  Responsible for implementing the CAPA Parameters after investigation.

14.  Responsibilities assign to check the effectiveness of CAPA.

15.  To ensure Co-ordination for IQ, OQ, PQ and qualification plan of the instruments.

16.  Responsible for Coordinate & present all relevant documents to external auditors and to ensure

that corrective measures are taken on any non-compliance finding.

17.   To Review method transfer protocols & reports & stability protocols.

18.  Responsible for rendering technical support to the Section in charges and managers.

19.  To Review various submissions to General Export and other regulatory markets related to quality

control.

20.  Responsible for review of data for integrity.

21.  To review of Hold time study protocol & report.

22.  Responsible for Review of comparison protocol & report of multimedia DRP & Dose dumping

between RLD & exhibit batches.

23.  Responsibilities of supervising inspection of raw material which improved product quality.

24.  To complete quality projects within time by proper planning & execution of planning.

25.  To ensure the Implementation of several measures to identify deformities, malfunctions or other

abnormalities such as Periodic verification of instruments/Equipment / components / products,

Trending of failures.

26.  To Coordinate with various cross functional groups for timely availability of API/RM, PM ,

manufacturing area (Production), Analytical documents (Like Method Transfer, Specifications,

Analytical Testing procedures etc.) & Quality control facility (Like column, critical chemicals

working standard & impurities).

27.  To provide input & review of process performance qualification protocol for common blend,

Compression for exhibit batches & Scale up batch.

28.  To Prepare and evaluate trends in quality system to monitor effectiveness and

utilize statistical methods for analysis.

29.  To plan and organize the daily working schedule of QC team.

30.  To execute monthly report and annual budget for QC department.

31.   To Ensure technical development of QC resources, systems and processes to drive long term

sustainable quality as well as efficiency.

32.  Responsibilities to plan out all QC resources and activities in relation to company objectives

and set targets.

33. Responsible for Performing & complying with Internal & External Audits

Desired Candidate Profile

Perks and Benefits