Kaztronix
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Quality Data Reviewer
Job Description
QA Data Reviewer
1. Empower(HPLC) calibration parameter
2. HPLC audit trail review
3. Dissolution calibration parameter
4. Method validation parameter
5. PH meter calibrate buffer solution
Performs critical in-depth review of all scientific data for Quality Control laboratory documents under general supervision.
Under the direction of QA management, this individual :
Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.
Demonstrates a thorough knowledge of approved SOP s, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.
Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.
Supports systems to ensure the successful completion of Departmental goals and objectives.
Other tasks as assigned by the Manager.
Experience:
1. Empower(HPLC) calibration parameter
2. HPLC audit trail review
3. Dissolution calibration parameter
4. Method validation parameter
5. PH meter calibrate buffer solution
Performs critical in-depth review of all scientific data for Quality Control laboratory documents under general supervision.
Under the direction of QA management, this individual :
Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.
Demonstrates a thorough knowledge of approved SOP s, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.
Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.
Supports systems to ensure the successful completion of Departmental goals and objectives.
Other tasks as assigned by the Manager.
Experience:
- Minimum of a Bachelors.
- Knowledge of pharmaceutical analysis.
- Ability to review laboratory records with minimal supervision within the framework of cGMP/GLP for analytical laboratories.
- Good understanding of EHS and OSHA safety guidelines.
- Knowledge of USP, ICH, FDA, and DEA regulations.
- Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
- Demonstrated excellent communication: verbal, written and presentation skills.
- Minimum of three (3) years of experience in a pharmaceutical environment with a minimum two (2) years of experience in chromatography (e.G. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).
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