Job Description for QA Data Reviewer
RESPONSIBILITIES:
- Review laboratory notebooks and all analytical data originating from in-house and outside contact testing labs.
- Review ·analytical method validation/protocols, method verification protocols/ reports, draft methods, and other relevant analytical data.
- Review calibration data of laboratory equipment to ensure compliance with SOPs, CGLP and cGMP.
- Ensure all lab and manufacturing related documentation is current, accurate and in the manner required.
- Ensure all activities related to stability testing are complete within the stability timeframe.
- Prepare and review the stability data, stability summary reports, certificate of analysis and any documentation required for filing of ANDA''s.
- Review all compendial methods and procedures, as needed.
- Review laboratory related deviations, OOS, OOT and other investigations.
- Review and maintain all documentation (equipment qualifications, calibration reports, archived logbooks\ notebooks, GMP documents, etc.).
- Review all production/analytical equipment qualification (IQ/OQ/PQ) and calibration documents.
- Review batch evaluation protocols/reports, batch records and other production related documents, as needed.
- Review manufacturing deviations and investigations.
- Ensure all activities are documented in a legible manner following established formats and good documentation procedures.
- Coordinate the review of ANDA projects as per priority.
- Draft, review and update ·SOPs to be compliant with the current regulatory guidance and provide official copies of approved documents to the respective departments, as needed.
- Review QA systems and identify gaps for remediation.
- Promote an environment of continuous improvement and enhance efficiency & effectiveness of the data review process
- Perform other duties as assigned.
·.QUALIFICATIONS
- Bachelor's Degree in Chemistry, Pharmaceutical Sciences, Biology or equivalent is required.
- Master's Degree in any of the above disciplines is preferred
- 5 years of pharmaceutical industry experience required.
- Proficiency is writing and reviewing reports, protocols and SOP's, and in filing ANDAs.
- GLP/cGMP documentation experience is a must.
- Prior experience reviewing laboratory and manufacturing deviations and investigations.
- Knowledge of QA systems.
- Excellent verbal and written communications skills.
- Strong interpersonal and relationship building skills.
- Proficient in Microsoft Word, Excel and PowerPoint.
Job Type: Full-time
Pay: $65,000.00 - $80,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
