Alya Patel Email & Phone Number

Mississauga, Ontario, Canada

• Review GMP related documentation (Certificate of Analysis, Certificate of Manufacturing, Batch records)• Prepare release reports for product release in Canadian market.• Perform label review on “NHPs” according to Canadian requirements.• Prepare “Finished Product Specifications” for Multiple Products.• Provide support during audits and inspections.• Prepare and review “Stability Protocols” according to Canadian requirements.• Prepare new and revise “Standard Operating Procedures (SOP)”.• Prepare “Annual Product Quality Reports (APQRs)”• Provide assistance to the QA Senior Manager.• Responsible for review and documentation of product returns in accordance with current GMP guidelines.

Mississauga, Ontario

Mississauga, Ontario

Toronto, Canada Area

Kheda, Gujarat

• Developed and maintained Department’s documents. • Drafted Chemical, Microbiological, Packing Materials, Instrument Operations and Calibration Standard Operating Procedures (SOPs) during Company’s title change. • Drafted Specifications and Standard Test Procedures for Active Pharmaceutical Ingredients (APIs), Excipients and Packing Materials as per current guidelines (Indian, British, European and US Pharmacopoeia) • Initiating Change Controls for any planned deletion/addition to Approved Document and/or introducing new document into Master Documentation Record. • Supervised Packing Material testing and reporting on daily basis. • To approve / reject any Packing Material that does not comply with Company’s standards.• Meeting with suppliers / vendors on receiving low quality packing materials and /or rejection of raw materials

•Performing quality testing of Raw and Packing Materials (Sugar, Carbon Dioxide, Fruit Pulps, Closure, Crowns, Glass bottles, PET preforms, etc.) •Maintaining test records, Internal audit records, Internal and external instrument calibration schedule and reports. •Daily auditing of Storage facilities for Raw and Finished products as per Company’s guidelines.•Training new recruits and Co-workers on Sampling and testing methods, Hazard Analysis Critical Control Point, Personnel Protective Equipment and Good Manufacturing Practices.•Meeting with suppliers / vendors on receiving low quality raw / packing materials and/or rejection of materials.

• responsible for maintaining pure cultures of microbial and fungal cultures• conducting lectures and practicals to 2nd & 3rd year B.Sc students.

M.Sc, Industrial Microbiology, Environmental Microbiology

Bachelor'S Degree, Microbiology, General