Openings in Strides arco lab for Group leader in ARD, Stability management and GLP - QMS

 

About Strides 

Strides started in 1990 as a generic industry, currently with 70 DMF files across EU,US & Canada, with 50 patents filed and 20 products in pipeline. The company has 2 US-FDA approved API facilities and 1 EUGMP approved solid oral manufacturing facility.

The portfolio of Strides spread with 30 therapeutic segments with specialized oncology medications and diagnostic media. Company having state of art technology facilities with infrastructure from conceptualization to regulatory submission. The R & D centers is established in 80,000 square feet work place with advanced technology in hand to produce cost effective medicines.

Produces wide verity of products with vast scope of reducing diseases and available to all people. Their mission is to have continuous improvement and inclusive work culture with customer satisfaction is the DNA of Strides

About the Job

We have openings in Quality control - Analytical department- Stelis Unit 2 . 

Job 1 :  Stability Management - Group Leader.

JD: Excellent Knowledge in injectable stability sample management in regulated market.

-Good knowledge in basic and advanced analytical techniques.

-Understanding and trouble shooting of the analytical instruments and methodology.

-Thorough knowledge in the OOS/OOT/deviations investigation.

-Day to day analytical planning based on the priorities.

-Interaction with cross functional teams and customers.

-Good knowledge in technical write up’s 

-Good knowledge on ICH Guidelines 

-Extrapolation and interpretation of the stability data. 

Job 2 : Analytical method validation/verification - Group Leader 

JD  :    Excellent knowledge in Analytical method validation/verification and transfer in the regulated market.

-Good knowledge in the method validations like HPLC/UPLC/GC. etc.

-Good knowledge in Analytical method transfer as per the guidelines.

-Understanding on the methodology and trouble shooting knowledge in validation and transfer.

-Knowledge on the stability indicating methods and mass balance interpretation.

-Day to day planning based on the priorities.

-knowledge in technical write ups.

-Good knowledge in AMV/AMT deviations investigations.

Knowledge on cleaning method validations.

Job 3  :  GLP - QMS - Team Leader

JD  :    -Good understanding on the Quality management system.

-Good knowledge in Good laboratory practices.

-Understanding and interpretation of the data integrity .

-Knowledge on sample/standard/column/impurities/chemicals /reagents management.

-Knowledge on Instruments on calibration master schedule preparation plan and execution.

Knowledge on calibration failure investigations.

-Technical write up

People management, cross functional teams interaction.

-Instruments breakdown management, interaction with vendors to rectify the same.

Qualification of the instruments .

Knowledge on the computer system validations

Interested candidates can share resumes to [email protected]