About the Company :
The firm have more than 10000+ employees and is founded in 1876 and have offices more than 18 countries. The firm have head quarters in Indiana polis. The firm have more than 145 year of excellence and have expert medical professionals with the core values in integrity, excellence and respect for people. During the pandemic times it involved in delivering Covid medicines. The firm have a Nobel prize awarded at 1928 with the liver extract for anemia. The company have many block buster molecules like Cymbalta and have scope of large and small molecular development. The firm have oncology division specialized in delivering world class medicines.
About the Job
Experience required : 16-18 years with a minimum experience of 8-10 years spent in Quality operations and audit related departments
Experience in Pharmaceutical quality systems and need to have hands on experience related to the departments.
required to have experience in good manufacturing regulations and standards in relation to Canada, US FDA, MHRA and ANVISA and TGA
required to have good good national and strong attentional skills and able to handle guidance documents associated with ICH, WHO, ISO and ISPE etc
able to work independently or in a deal regime departmental and organisational growth able to have expertise in systems like quality management track wise and Systems applications (SAP) and products LIMS would be an asset.
able to handle and manage project in a fast pace environment and able to media to all global business _ethics and compliance programm
required to support in development and remediation to drive complaints to regulatory and Apotex standards Evaluate the appropriateness of proposed CAPA for the insurance happened.
required to identify deficiencies and appropriately handle the business stakeholders such as global active pharmaceutical ingredients supplier quality external manufacturing quality business development and site heads as well as global supply and technical operations team
Needed to have knowledge on risk assessments and profiling the Apotex suppliers to determine the audit frequencies based on the risk associated with the suppliers
required to have technical and regulatory knowledge and association with internal external stakeholders, able to share knowledge and collaborate with auditors globally and locally enhanced the expertise and New existing auditors.
required to be accountable for the monthly quarterly and yearly audit matrix and able to demonstrate the behavior's like collaboration passion career and preservance
able to handle any task like product recalls investigations deviations external systems system to ensure the highest risk areas are in scope of audit
should compile process the data to precise accuracy and chronological order for reports and allocate time for appropriate review of audit reports
able to handle the tasks with due diligence and regenerate the recommendations to enhance the quality and compliance of new suppliers able to provide the remediation for mitigation of the quality related to Apotex supply chain.
candidate hired will be responsible for auditing Apotex suppliers encompassing audit scheduling execution and closure of orders Accountable for applying regulatory standards and responsible for enhancing the learning leverage the existing systems.