Pharma Specialist Post Vacancy @ Novartis – Apply Online
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Job ID 293998BR
Position Title Specialist
A Bachelor of Science degree in a scientific discipline. English
• Minimum 3 years in the pharmaceutical industry with an em-phasis on Quality Assurance. Demonstrated cGMP knowledge. Knowledge of cGMPs. (ICH Guidelines)
• Applicable PC software knowledge and prior experience with Dragon, TEDI, SAP, AQWA, LIMS (Laboratory Information Management) Systems.
• Possess the ability to manage multiple tasks and work independently in ambiguous situations.
• Excellent technical writing skills, file organization, and the ability to manage data is required.
• Knowledge of stability regulations and its application to the industry.
• Excellent organizational, communication skills and interpersonal skills.
• Interpretation/Analytical data.
Responsible for the preparation of the Annual Product Quality Review (APR/PQR) Report for Novartis marketed products and selected third-party products in accordance with company and government regulations.
Your responsibilities include, but not limited to
• Responsible for the preparation of the Annual Product Quality Review (APR/PQR) Report for Novartis marketed products and selected third-party products in accordance with company and government regulations.
• Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, variation.
• Responsible for the preparation of the APR/PQR Report according to the established schedule.
• Responsible for collecting stability data and reports for product related evaluations. (e.g. compliance investigations, divestitures, product transfers, validation. etc.)
• Responsible for writing and updating applicable SOP’s.
• Support maintenance of APR/PQR schedule.
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