Greetings from Dr. Reddys!
Please find the below details with regard to walkin drive for the multiple positions in Analytical Method Development and Validations for Visakhapatnam location for API and OSD business units.
Date: 19th Dec, 2015 (Saturday)
Time: 9:00 AM
Venue:
Dr Reddys Laboratories Limited
Survey No. 44, Bachupally,
Qutubullapur Mandal
Bachupally Campus,
Medak Dist - 500 043
Contact person: Pulla Rao, Human Resources
Please find the below job description for your reference.
About the Role
This role is required to ensure high standards Analytical Quality and Compliance (Quality Control) of test procedures in the Finished Product. Candidate should have hands on experience with Finished product Analytical methods validation, method transfers and calibration procedures.
Purpose
* To validate the finished products analytical methods in Quality control laboratory following applicable SOPs and cGMPs. Participate in Intermediate precision study and also involve in analytical method transfers and ensure the Good documentation practices.
Job Description / Roles and Responsibilities
Analytical Methods Validation and Method Transfers
* To perform the analytical methods validation by using instrumental techniques like HPLC, GC, Dissolution, Potentiometry/ Auto titrator, UV...etc. and strictly adhere to applicable SOPs and other relevant procedures.
* Possess good knowledge on Empower 2 or 3 software and hands in experience on HPLC, GC, Dissolution (Electrolab and Distech), UV, Potentiometry instruments.
* Knowledge on instrument calibration procedures.
* Hands on experience on analytical method validations (Finished products, APIs, Excipients..)
* Review of analytical development reports prior to the initiation of method validation and identifying potential gaps in the document to avoid abnormalities during AMV.
* Preparation of method transfer and validation protocols and ensure the right first time.
* Execution of analytical method transfer and validation activity.
* Preparation of justification reports for the supplement validations.
* Possess sound knowledge of ICH, USP and other Regulatory requirements w.r.t. Analytical method validations and Transfers.
* Ensure the compliance to 21 CFR Part 11 requirements.
Quality Compliance
* Work closely with Supervisor QC and participate in weekly / monthly review meetings to understand the timelines and priorities.
* Resolve any analytical method related issues together working with Analytical experts / SME's.
* Thorough verification of all the analytical data generated and ensure the online documentation.
* Provide inputs for any analytical quality improvements.
Regulatory Audits
* Participate and provide the support during regulatory and health authority audits
* Ensure Laboratory for any time audit readiness.
* To participate in investigations (as per the approved SOPs) and preparation of reports
Key Performance Indicators
* Analytical method validations & Transfers - Effectiveness & Timeliness
* Calibration of instruments as per the scheduled
* Analytical data records and reviews (both paper and e-records)
* Meeting the set timelines
* Analytical investigations in a timely manner (with scientific rationale)
Please carry the following documents at the time of interview
1. Updated Resume
2. Last three months payslips
3. Annual CTC breakup or increment letter
NOTE: 60% IS MANDATORY ON HIGHEST QUALIFICATION
Thanks and warm regards,
Pulla Rao
Human Resources
Dr. Reddys Laboratories Ltd.
Hyderabad
Please find the below details with regard to walkin drive for the multiple positions in Analytical Method Development and Validations for Visakhapatnam location for API and OSD business units.
Date: 19th Dec, 2015 (Saturday)
Time: 9:00 AM
Venue:
Dr Reddys Laboratories Limited
Survey No. 44, Bachupally,
Qutubullapur Mandal
Bachupally Campus,
Medak Dist - 500 043
Contact person: Pulla Rao, Human Resources
Please find the below job description for your reference.
About the Role
This role is required to ensure high standards Analytical Quality and Compliance (Quality Control) of test procedures in the Finished Product. Candidate should have hands on experience with Finished product Analytical methods validation, method transfers and calibration procedures.
Purpose
* To validate the finished products analytical methods in Quality control laboratory following applicable SOPs and cGMPs. Participate in Intermediate precision study and also involve in analytical method transfers and ensure the Good documentation practices.
Job Description / Roles and Responsibilities
Analytical Methods Validation and Method Transfers
* To perform the analytical methods validation by using instrumental techniques like HPLC, GC, Dissolution, Potentiometry/ Auto titrator, UV...etc. and strictly adhere to applicable SOPs and other relevant procedures.
* Possess good knowledge on Empower 2 or 3 software and hands in experience on HPLC, GC, Dissolution (Electrolab and Distech), UV, Potentiometry instruments.
* Knowledge on instrument calibration procedures.
* Hands on experience on analytical method validations (Finished products, APIs, Excipients..)
* Review of analytical development reports prior to the initiation of method validation and identifying potential gaps in the document to avoid abnormalities during AMV.
* Preparation of method transfer and validation protocols and ensure the right first time.
* Execution of analytical method transfer and validation activity.
* Preparation of justification reports for the supplement validations.
* Possess sound knowledge of ICH, USP and other Regulatory requirements w.r.t. Analytical method validations and Transfers.
* Ensure the compliance to 21 CFR Part 11 requirements.
Quality Compliance
* Work closely with Supervisor QC and participate in weekly / monthly review meetings to understand the timelines and priorities.
* Resolve any analytical method related issues together working with Analytical experts / SME's.
* Thorough verification of all the analytical data generated and ensure the online documentation.
* Provide inputs for any analytical quality improvements.
Regulatory Audits
* Participate and provide the support during regulatory and health authority audits
* Ensure Laboratory for any time audit readiness.
* To participate in investigations (as per the approved SOPs) and preparation of reports
Key Performance Indicators
* Analytical method validations & Transfers - Effectiveness & Timeliness
* Calibration of instruments as per the scheduled
* Analytical data records and reviews (both paper and e-records)
* Meeting the set timelines
* Analytical investigations in a timely manner (with scientific rationale)
Please carry the following documents at the time of interview
1. Updated Resume
2. Last three months payslips
3. Annual CTC breakup or increment letter
NOTE: 60% IS MANDATORY ON HIGHEST QUALIFICATION
Thanks and warm regards,
Pulla Rao
Human Resources
Dr. Reddys Laboratories Ltd.
Hyderabad
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