QC Technical Reviewer

Aurobindo Pharma Ltd.•Durham, NC

32d•Onsite

About The Position

This position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses and other technical documents for the release of raw materials, finished products and stability monitoring. Functions will include supporting Laboratory investigations and writing technical reports for method transfers/verifications as it pertains to components, raw materials and finished pharmaceutical products. This positions supports ensuring compliance with standard operating procedure and all regulatory requirements that may arise. This position is responsible for providing training to department employees as required stemming from deviations and/or laboratory investigations. This position will also reponsible for anyother compliance task assigned by the department Head.

Requirements

B.S/MS degree in engineering/Chemistry/Scientific field required
Minimum 3 years of experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the pharmaceutical industry
Familiarity with Empower 3 data collection system
Working knowledge of cGMPs and regulatory requirements as they apply to pharmaceutical testing.
Familiarity with compendial methods (USP/NF, EP, JP, BP, etc.)
Experience in investigation/deviation management
Technical writing skills with experience related to both laboratory and manufacturing investigations

Responsibilities

Technical review of raw data for the QC group
Technical review of method transfer/verification protocols
Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols
Review, manage, and monitor stability trend tables
Support investigations that arise in the QC testing of raw materials/finished products as needed
Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scope of the investigation to determine the appropriate root cause
Support the implementation of corrective actions, complete the trending analysis, and determine product disposition as applicable
This role will foster a collaborative relationship with manufacturing and laboratory personnel, focusing on high-quality, systematic investigations, meaningful corrective actions, and reducing the rate of deviation generation. Provide support to determine appropriate corrective actions to prevent the recurrence of the deviation
Track the effective measure of each implemented corrective action and take appropriate action if and when required
Provides oversight and final review of investigations to ensure adherence to cGMP, rigorous technical content, investigation clarity, and completeness