Quality Reviewer

Role & responsibilities

1.

To allocate work and plan the activities of Lab QA team

2.

Responsible for ensuring GLP compliance in Quality control department.

3.

To develop and maintain a quality system in accordance with cGMP by enforcing adherence to the procedures, work instructions and Quality Management Systems-requirements as per regulatory guidelines.

4.

To Review Analytical reports of Raw Materials, Packaging Materials, In process, Finished Products, Stability products, Microbiological analysis, Analytical method transfer, Process Validation, Data for Qualification of Instrument, Calibration reports, working standard.

5.

To review the reports for completeness, GDP compliance.

6.

To approve Certificate of Analysis (COA) and Analytical reports.

7.

To perform laboratory round on periodic basis to ensure GLP/GDP practices.

8.

Responsible for Stability management, monitoring of stability chamber, review of Stability Protocol, Selection of batches for stability study.

9.

To review Back up and retrieval of electronic data on periodic basis.

10.

To participate and review Investigation of OOS / OOT /Lab incident results.

11.

To perform Gap analysis of the QC SOP

12.

To check and approve QC instrument qualification/validation

13.

To participate in Audit preparation and Audit Compliance.

14.

To perform the Self Inspection to rectify the system error, implementation in system. Review and compliance of the corrective action report of internal audit queries given to concerned department for improvement

15.

To prepare and review SOP.

16.

To review the adequacy  of analytical data generated on systems/Instrument and linked to documents, logbooks, records.

17.

Approval of QC specification, Standard testing procedure, test data sheet for Raw material, Packing material, ln-process, Finished product and Stability. (Hard copy and ERP)

18.

To provide training to QC, QA as and when required.

19.

Responsible for any other activity as and when assigned by Head Quality or Head QA

Preferred candidate profile Candidates preferred form reputed pharmabackground