APQR Specialist - Novartis - Hyderabad

Job description

Job Description

Responsible for the preparation of the Annual Product Quality Review (APR/PQR) Report for No-vartis marketed products and selected third party products in accordance with company and gov-ernment regulations.
Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, varia-tion. 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. com-pliance investigations, divestitures, product transfers, validation. etc.)  Responsible for writing and updating applicable SOP's.  Support maintenance of APR/PQR schedule.  Responsible for the APP/PQR Report recordkeeping progress and flag any delays on time  Responsible for scheduling meetings with the APR Team to determine and assign follow-up action items, if required.  Support ESO QAM responsible for the review of the APR/PQR and stability reports from CMO's to ensure compliance with Novartis requirements. Communicate with CMO's, as required.

Desired profile

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.  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 inde-pendently in ambiguous situations.  Excellent technical writing skills, file organization, and the abil-ity to manage data is required.  Strong analytical background.  Knowledge of stability regulations and its application to the industry.  Knowledge of cGMPs. (ICH Guidelines)  Excellent organizational and communication skills.  Excellent interpersonal skills including use of tact, diplomacy, discretion and judgment.  Interpretation/Analytical data.

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