Dr. Reddy's Laboratories Ltd. - Walk-in Drive for Method Development and Method Validations at Indore for the OSD and Injectables Manufacturing Facilities at Visakhapatnam, 19 JUNE

Job Description

Dr. Reddy's Laboratories Ltd. - Walk-in Drive for Method Development and Method Validations at Indore for the OSD and Injectables Manufacturing Facilities at Visakhapatnam, 
Drive Date : 19th June, 2016 (Sunday)
 
Venue: 
Hotel Lemon Tree, Indore

Contact person: KR Srinivas, Human Resources

Qualification: M. Sc or B. Pharm or M. Pharm or Ph.D

Please find the below job description:

Analytical Methods Validation and Method Transfers 

1. To perform the analytical methods validation by using instrumental techniques like HPLC, GC, LCMS, GCMS, NMR, ICPMS, XRD, DCS TGA, AAS, Dissolution, Potentiometry / Auto titrator, UV etc. and strictly adhere to applicable SOPs and other relevant procedures. 

2. Possess good knowledge on Empower 2 or 3 software and hands in experience on HPLC, GC, Dissolution (Electrolab and Distech), UV, Potentiometry instruments. 

3. Knowledge on instrument calibration procedures.

4. Hands on experience on analytical method validations (Finished products, APIs, Excipients..)

5. Review of analytical development reports prior to the initiation of method validation and identifying potential gaps in the document to avoid abnormalities during AMV.

6. Preparation of method transfer and validation protocols and ensure the right first time.

7. Execution of analytical method transfer and validation activity. 

8. Preparation of justification reports for the supplement validations.

9. Possess sound knowledge of ICH, USP and other Regulatory requirements w.r.t. Analytical method validations and Transfers.

10. Ensure the compliance to 21 CFR Part 11 requirements.

Quality Compliance

1. Work closely with Supervisor QC and participate in weekly / monthly review meetings to understand the timelines and priorities. 
2. Resolve any analytical method related issues together working with Analytical experts / SMEs.
3. Thorough verification of all the analytical data generated and ensure the online documentation.
4. Provide inputs for any analytical quality improvements.

Regulatory Audits 
1. Participate and provide the support during regulatory and health authority audits
2. Ensure Laboratory for any time audit readiness. 
3. To participate in investigations (as per the approved SOPs) and preparation of reports

Key Performance Indicators 
1. Analytical method validations & Transfers Effectiveness & Timeliness
2. Hands on exposure in handling of multimedia dissolution profile analysis for Innovator and test
3. Analytical data records and reviews (both paper and e-records)
4. Meeting the set timelines
5. Analytical investigations in a timely manner (with scientific rationale)

Note:  Minimum stability of two years in current or previous company is mandatory

Candidates matching below criteria can Walk-in directly with their updated resume and latest increment letter.