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Specialist - Quality Operations

AT Novartis
Novartis

Specialist - Quality Operations

Hyderabad, India

Summary

Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility.

About the Role

Major accountabilities:

  • Coordination and management of analytical method transfers and stability studies. Compilation of data reports
  • Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
  • Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc
  • SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
  • Validate spreadsheets
  • Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
  • Author, approve and archive Impurity risk assessments - Nitrosamines, residual solvents, etc
  • Trend and report all QMS elements as per the request
  • Monitor, trend and report Health Safety and Environmental parameters
  • Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
  • Perform activities of a Quality Control expert as defined by the respective sites
  • Support regulatory requirements - routine queries, Chromatogram requests
  • Compile Quality performance management decks
  • Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed

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Key performance indicators:

  • On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration

Minimum Requirements:

  • Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
  • Min 5 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
  • GxP knowledge, Basic IT knowledge
  • Good communication, presentation and interpersonal skills
  • Experience of working closely with the global stakeholders

Skills:

  • Analytical Method Development/ Method Validations/Method Transfers
  • Quality Control / In-process / Raw materials /
  • Stability studies / Supportive stability studies
  • Investigations like OOS/OOE/OOT
  • Pharmacopoeia / Health Authority / Regulatory requirements
  • GxP / Data Integrity / Quality and Compliance.
  • SAP/HPLC/UV

Languages :

  • Fluent in English (written and spoken)

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Operations

Business Unit
Innovative Medicines

Location
India

Site
Hyderabad (Office)

Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area
Quality

Job Type
Full time

Employment Type
Regular

Shift Work
No

Client-provided location(s): Hyderabad, Telangana, India
Job ID: Novartis-REQ-10015984
Employment Type: Full Time