MARINA AZAM

• Approve finished product releases as a qualified individual on behalf of QAP
• Determine root cause of deviation and product non conformance and implement appropriate corrective and preventive measures
• Initiate Change Controls (CCR) and revise GMP documentation as driven by internal SOPs.
• Support customer complaint and other investigations by logging complaints, gathering relevant information, issue final investigation reports.
• Maintains complaints and investigations databases- Trend complaints and investigations and support issuance of trending reports
• Identify recurring non-conformances and ensure appropriate actions are taken.
• Provide support to CAPA and Non-Conformance Investigation programs as requested by Manager.
• Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements.
• Works with other departments to proactively build quality into the processes and systems
• Administrative support to team as required.

• Ensure all labels and secondary packaging comply to current Cannabis Regulations and in-house specifications
  • Work closely with Quality Control to ensure all 3rd party lab results are reviewed and product potencies and packaged on dates are verified prior to approving labels
  • Initiate Master Label Approval form. Implement, manage, and provide project-related support to product development and manufacturing activities.
  • Work with cross-functional team to meet project objectives .
  • Identify and communicate key project issues/concerns cross-functionally and make recommendations to the portfolio manager.
  • Responsible to create and revise technical documents including specifications, SOPs, and job aids etc.

• Established stability protocols and perform stability studies by following ICH guidelines and maintains all records of stability products.
  • Maintains stability databases- Trend stability results and support issuance of trending reports
  • Carry out routine analysis of production batches and perform calibration of all laboratory instruments.
  • Perform comparative analysis and post marketing surveillance of all different product aspects (physical aspects, chemical aspects, and packaging)
  • Hand on experience of working with laboratory instruments like HPLC, Dissolution apparatus, spectrophotometer etc.