Job Description:
Job Purpose
Support PLS-M&SO delivery in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies by implementing processes, systems and tools that realize the Quality Operations services across Novartis divisions.
Major Accountabilities
Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows like technical complaints, technical deviations, change control management, regulatory & printed packaging material compliance checks, regulatory submission & variation coordination, supplier qualification & management, product quality reviews and trends, performance reporting, artworks review and monitoring, audit support and application user support within PLS-M&SO.
Create and review GxP documents and reports like trends, performance, qualification, validation and technical investigations.
Hold and manage key accounts in workflow applications (like SAP, Dragon, TEDI etc.) to ensure appropriate execution of service deliverables.
Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc.) and perform follow-up actions if required.
Escalate service related GxP and non-GxP issues to appropriate level within PLS M&SO to ensure timely investigation and compliance with local and global operating procedures.
Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
Regularly communicate with customers and partners to collect feedback on support services, report deliverable status and continuously acquire process knowledge.
Support implementing service quality and process improvement projects within PLS M&SO organization.
Adherence to the service KPIs and ensuring the service dashboard, order management framework and time sheet is always kept updated.
Ideal Background
University or academic degree in Chemistry, Microbiology, Biotechnology, Pharmacy or equivalent
Experience in chemical/pharmaceutical industry. Min. 1-3 yrs Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Analytical Chemistry Associate/Scientist
Keyskills:
Pharma Quality Compliance Change Control Service Level Process Improvement Service Quality Quality Standards
Desired Candidate Profile:
Please refer to the Job description above
Education-
UG: B.Pharma – Pharmacy
PG:MS/M.Sc(Science) – Any Specialization, Bio-Chemistry, Organic Chemistry, M.Pharma – Pharmacy
Company Profile:
Novartis Healthcare Pvt. Ltd.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.