Team Member

1. 1. To follow Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
2. To follow Laboratory Safety Standards and Practices.
3. Responsible for the execution of IP/ FP /Stability samples analysis.
4. Responsible issuance of new STPs/Specifications from QA and submission of obsolete STPs/Specifications to QA.
5. Responsible to report/highlight discrepancies in Procedures / Products / People practices/ Materials/ Systemic issues to the Group Leader and Functional Head in time.
6. Responsible for perform the analysis as per the respective SOP or STP or GTP.
7. Responsible for do the documentation online and error free.
8. Responsible to ensure Calibrated Instruments / Equipment are used for analysis.
9. Responsible for maintenance & issuance of Working / Reference / Impurity Standards Used for analysis.
10. Responsible to operate the Instruments / Equipment with utmost care and as Instructed in the relevant SOP.
11. To report Incidents / OOS / OOT and unexpected results in time to the Group Leader.
12. Responsible for management of chemicals, solvents, Reagents, standards& miscellaneous Materials from Engineering store.
13. Responsible for adherence to the Stability Management procedure.
14. Responsible for ensuring the disposal of IP/FP/Stability samples after the Completion of analysis.
15. Responsible for support to perform all the LST related activities.
16. Responsible for maintenance & issuance of Columns for chromatography used for Analysis.
17. Responsible for comply any other responsibilities given by the Supervisor.
18. Responsible for support during Breakdown Maintenance and Preventive Maintenance of Instruments/ Equipment.
19. Responsible for proper maintenance of Documents, Register & Booklet and reconciliation As applicable.
20. Responsible for ROA hard copies submission to QA as per instruction of supervisor.
21. Responsible for support during filing of documents.
22. Responsible for adherence to stability management procedure.
23. Responsible for stability management through SAP activities
24. Responsible for analytical method validation and analytical method transfer activities.

Qualification

Educational Qualification

A B.Pharm. or Post-Graduation (Life Sciences)

Minimum Work Experience

4 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development

Skills & Attributes Technical Skills:

• A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
• In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs.
• Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities.
• Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market.
• Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements.
• Ability to understand and implement organizational policies and ensuring compliance.

Behavioural Skills:

• Demonstrates a commitment to continuous learning.
• Strong communicating and influencing skills.
• Displays analytical and logical thinking abilities.
• Is self-motivated and takes initiative.
• Adaptability to the work environment, along with being a team player.
• Ability to go beyond boundaries, showcasing a proactive and innovative approach.

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Additional Information

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon...

" Benefits Offered

At Dr. Reddy's, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards...

" Our Work Culture

Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions...

For more details, please visit our career website at

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