Experience

Austofix

• Australia
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Associate

  • Jun 2022 - Present



HPS

• Morocco
• IT Services and IT Consulting
• 700 & Above Employee

• Pharmacy Technician

  • Apr 2022 - Jun 2022



Contract Manufacturing & Packaging Services Pty. Ltd.

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Officer

  • Sep 2020 - Feb 2022

  Leveraging my industry experience, I ensure compliance with all Therapeutic Goods Administration (TGA) regulations by reviewing scientific, technical, and legal documents. In addition, I deliver preventive and corrective actions by assessing quality deviations and root cause of customer complaints. Furthermore, I monitor and register new products on TGA website on regular basis. Moreover, I examine comprehensive data across different reports, including sterilisation, clinical evaluation reports, and risk management. Likewise, I retained record of allergens, up-to-date drug master files (DMFs), safety data sheets, product compliance documentation, declarations of conformity, and product registration certifications. Next, I manage regulatory enquiries and submission to government authorities and regulatory bodies. ♦ Examined and approved label claims and artworks in compliance with market and country requirements. ♦ Remained upgraded with significant changes in regulatory/legislative guidelines and product range of company by direct researching. ♦ Adapted output based on country requirements by crafting and submitting dossiers for different products. ♦ Gained comprehensive experience in Halal audits and Hazard Analysis and Critical Control Points (HACCP). ♦ Drove product compliance by liaising and negotiating with international and domestic suppliers for document and information collection.



SUN PHARMA

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Assistant

  • Jul 2015 - Jul 2017

  While holding this position, I assured quality of medications by researching, testing, and inspecting purity and strength. Consequently, I maintained appropriate work documentation of R&D department. Furthermore, I took quick action for saving drugs from contamination and degradation by verifying quality of raw materials, vaccines, stock levels, and other drugs. Not only but also, I focus on certifying drug ingredients, properties, and storage by analysing drug products across different stages. ♦ Ensured accuracy and adherence to regulations. ♦ Planned, supervised, examined, and reviewed quality of drugs by collaborating with multidisciplinary teams. ♦ Defined standards for pharmaceuticals drugs by planning, executing, and documenting procedures.



COMED CHEMICALS LTD.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA/QC

  • Dec 2013 - Dec 2014

  In this position, I administered all QA/QC documents within production unit. In addition, I also issued records of monthly calibration and batch manufacturing. As well, I examined and approved foils, carton labels, and insert of product while devising precise dossiers. Likewise, I minimised downtime by coordinating maintenance and conducted calibration of equipment on a daily basis. ♦ Retained product quality by inspecting parameters of medicines, such as capsules and tablets. In this position, I administered all QA/QC documents within production unit. In addition, I also issued records of monthly calibration and batch manufacturing. As well, I examined and approved foils, carton labels, and insert of product while devising precise dossiers. Likewise, I minimised downtime by coordinating maintenance and conducted calibration of equipment on a daily basis. ♦ Retained product quality by inspecting parameters of medicines, such as capsules and tablets.