Bsc Chemistry APQR Specialist Job Vacancy @ Novartis
Bsc Chemistry APQR Specialist Job Vacancy @ Norvatis. Career @ Norvatis. Bsc Chemistry candidates are invited for a job vacancy. Check out all the details on the same below:
Job Id: 250997BR
Job Title: APQR Specialist
Eligibility: BSc chemistry/ Pharmacy
Experience:
- Minimum 3 years in the pharmaceutical industry with an emphasis 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 independently in ambiguous situations.
- Excellent technical writing skills, file organization, and the ability 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.
- 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.
- 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.
