Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales.
Job Title : APQR Specialist
Job ID : 208129BR
Division : NBS
Major Accountabilities:
• Responsible for GMP/QMS/Hygiene/Good documentation practices compliance for area of assigned activity.
• To remain all time alert and responsible to ensure truthfulness of data for area of assigned activity as doer or checker..
• Would own the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, variation.
• Accountable 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.
• Supervises APR/PQR Report recordkeeping progress and flag any delays on time.
• Responsible for scheduling meetings with the APR Team to resolve and assign follow-up action items, if required.
• Support ESO qam responsible for the review of the APR/PQR and stability reports from cmo to ensure compliance with Novartis
Minimum Requirements:
- Should have a Bachelor of Science degree in a scientific discipline. English
- Minimum 3 years of in the pharmaceutical industry with an em-phasis on Quality Assurance.
- Should strive to demonstrate good cgmp knowledge.
- Strive to have applicable PC software knowledge and prior experience with Dragon, TEDI, SAP, AQWA, LIMS (Laboratory Information Management) Systems.
- He/ She should strive to possess the ability to manage multiple tasks and work independently in ambiguous situations.
- He / She should be excellent technical writing skills, file organization, and manage data is required.
- He / She comes in with a strong analytical background.
- He/ she would need to possess sound knowledge of stability regulations and its application to the industry.
- He / she would need to posses excellent knowledge of cGMP. (ICH Guidelines).
- Positively impact project and team deliverables
- Excellent organizational and communication skills.
- Excellent interpersonal skills including use of tact, subtlety, discretion and judgment.
- Interpretation/Analytical data.
