Title:  Senior Manager - 1

S.no.

Responsibilities

1.

Effectively manage the Site QC activities and resources necessary to smoothly run the QC operation at site.

2.

Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site.

3.

Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities.

4.

To approve and monitoring of the Capex/Opex and outside lab analysis.

5.

Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.

6.

Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams.To ensure that the response for Internal & External audit observations is provided within stipulated time frame.

7.

Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and QC systems at the site.

8.

Handling of QMS documents as per respective SOPs in a timely manner.To establish, validate, upgrade and implement the quality management system.

9.

Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle and to ensure scheduled qualification/validation and calibration of equipment/laboratory instruments.

10.

To assign the roles, responsibilities and authorities for persons in Quality Control.

11.

To monitor and ensure that RM/PM/IP/FP/Micro are released in time to meet market/customers’ requirements and Lab is being operated as per approved procedure.

12.

Responsible for handling, approval and monitoring of application like SAP, EWS, Track wise, LIMS (4.1.3), Partners, Medhas and EDMS.

13.

Act as system owner for Laboratory computerized systems including LIMS 4.1.3 and ensure laboratory computerized systems are validated for its intended use throughout its lifecycle.

14.

To perform and complete the approval activity in Medhas by approving UAM for periodic access review in LIMS 5.0.1.

15.

Implementation of new ideas to help in improving the competitiveness between all QC personnel.

16.

To coordinate with CQ / ADD / PDD / CC / HR/ Production / RMS / PMS / BSR.

17.

Review the Quarterly, Monthly, Weekly reports and send reports to CQ within timeline.

18.

To ensure appropriate Technology transfer (Analytical) are done as per standard Operating Procedure.

19.

To ensure that stability of the finished product is carried out as per approved stability protocol.

20.

To ensure product quality review as per defined time lines and wherever required appropriate action to be taken to improve quality of the products as per trend data.

21.

Communication with Qualified person and marketing authorization holder for various documentations and approval.

22.

To ensure and lead investigation of market complaints, product failures, and deviation and monitoring compliance to recommend corrective and preventive actions.

23.

To perform any additional responsibility assigned by Quality Head.