|Company||A Pharmaceuticals Company|
|Position||Specialist GMP QA Oversight|
|Required Experience||5-8 Years|
|CTC||As per the company standards|
|Posted On||01 Sep 2021|
|Application Deadline||01 Nov 2021|
Experience in Quality Assurance, change deviation request, quality management system tools
Qualification: Bachelors or PG Experience: 5 to 8 Years Job Description: 28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
Your key responsibilities:
Your responsibilities include, but not limited to:
• Provide support in preparation, review and approval of GMP documents including local and global SOPs, WP’s, Investigation reports, etc., where required.
• Ensure implementation of applicable Novartis QMS requirements at NTO GOC, QSC and CTS. Provide support as key user/ Super user for IT tools used for Quality Management System.
• Support departments in identifying gaps/ deficiencies in the established quality management system that can independently trigger, investigate and implement the necessary corrective action in line with current external and internal standards to ensure continuous evolution of the quality system.
• Provide timely and effective communication of any potential compliance gaps/risks in QSC, NTO GOC and CTS to the respective SPOCs or team lead and facilitate for resolution of identified gaps/ risks.
• Initiate, monitor and fulfill the timely review of APQR documents for all the ESO hubs/NTO that QSC supports.
• Provide quality support to Nitrosamine risk based evaluation/ Changes, as required. Initiate and implement quality improvement/simplification projects, wherever possible. Impart trainings on GMP/Data integrity and other relevant trainings, as required.
• Create various KQI’s/metrics for respective GxP activities for both NTO GOC, QSC and CTS for presenting in relevant forums. Provide quality support and approvals in MAP product supply process.
• Ensure all time readiness of the activities for internal/ Business partner audits (including data integrity audits), host audits, and manage audit action plans for timely closure of agreed CAPAs. Minimum requirements What you’ll bring to the role:
• Minimum 6 years of working experience in a pharmaceutical Quality Assurance or manufacturing, Quality Control, Supply chain.
• Profound knowledge of National/International pharma regulations. Exposure in implementing and continuously improving robust quality systems and processes, and maintaining global quality standards in regulated areas.
• Good knowledge of risk-based approaches in product lifecycle management. Excellent understanding of business processes, supply chain principles and practices as well as supporting systems and applications
• Good communication and interpersonal skills, Project management skills and Change management skills.
• Good application knowledge (SAP, AQWA). In-depth GxP knowledge, Quality Risk Management, broad IT knowledge, continuous improvement
• Skills to deliver virtual and F2F Facilitation trainings. Provide pragmatic solutions to ensure compliance applicable regulations. Experience of working closely with the global stakeholders and negotiation skills.