Duties and Responsibilities:

• Review the 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 that 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 the filling of ANDAs.
• Review all compendial methods and procedures, as needed.
• Review laboratory related deviations, OOS, OOT and other investigation.
• 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 of 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 the SOPs to be compliant with the current regulatory guidance and provide official copies of approved documents to the respective departments, as needed.
• Review the QA systems and identify gaps for remediation.
• Promote an environment of continuous improvement and enhance efficiency & effectiveness of the data review process.
• Perform other varied duties as required by QA Management.
• Meet project deadlines and performance standards as assigned.
• Comply with all Company policies and procedures, including safety rules and regulations.
• Perform other related duties as assigned.

Education:

• Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Biology or equivalent is required.
• Master’s degree in any of the above disciplines is preferred. 

Required Experience/Skills:

• Minimum of 5 years of quality experience in the pharmaceuticals industry.
• Proficiency in 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
• Strong interpersonal and relationship building skills.
• Excellent verbal and written communications skills.
• Strong computer skills with use of MS Word, Excel, and PowerPoint