Quality Control

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly.

The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

As a key site Quality Employee the QA Investigator will be responsible for assuring that the investigations are conducted and written in compliance with all cGMP regulatory as well as facility requirements. This individual will be responsible for:

• Conducting investigations, including preparation of investigation reports, follow‑up with other departments for closure on time, and review of analytical data related to investigations.
• Handling QAMS‑related activities of QC, including Deviation, OOS, CAPA management, and monitoring CAPA effectiveness, ensuring all QAMS activities close on time.
• Managing Quality Control GLP activities, including standard, column, calibration management and 21
  
  CFR compliance of software.
• Leading, conducting, writing, reviewing and approving investigations for Deviations and Market Complaints.
• Responsible for the investigation/CAPA SOPs as well as performing training to employees.
• Assist QC and Compliance as deemed necessary by the Head of QC
• Lead investigations for deviations, out-of-specification (OOS) results, and non-conformances.
• Use root cause analysis tools like 5 Whys
  , Fishbone diagrams
  , and FMEA to identify causes
• Document findings and ensure timely closure of investigations.

• Develop and implement CAPAs based on investigation outcomes.
• Track and trend deviations to identify recurring issues and systemic risks

• Review analytical testing of APIs, drug substances, finished products, packaging materials, and stability samples
• Ensure testing is performed in compliance with cGMP
  , GLP
  , and data integrity standards.

• Author and revise SOPs related to investigations and quality control.
• Ensure documentation is complete, accurate, and compliant with regulatory standards

• Participate in internal audits and gap analyses.
• Support regulatory inspections by providing investigation reports and CAPA documentation

• Manage sample storage and ensure proper documentation of analytical results.
• Verify analytical reports for completeness and compliance

• Work closely with QA, QC, production, and regulatory teams to resolve quality issues.
• Provide training on investigation procedures and quality standards.