Require Quality Manager at Novartis – Apply before 20th July 2024

Pharmaceuticalcarrier; Hyderabad; On-site; INR 8,00,000 - 12,00,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Manager in Hyderabad to oversee GXP-validated IT systems and ensure compliance with quality standards. The ideal candidate will have extensive experience in the pharmaceutical industry and skills in project and process management. This role requires a Bachelor’s or Master’s degree in a related field. Join a diverse workforce committed to quality and inclusion.

Qualifications

• Over 9 years of experience in the chemical/pharmaceutical industry or over 3 years in a related field.
• Experience with IT systems as a Key User or System Owner.
• Knowledge of drug development process or quality assurance.

Responsibilities

• Oversee GXP-validated IT systems development and maintenance.
• Document, test, and implement IT operational requirements.
• Ensure compliance with information security and quality standards.
• Assist with internal audits and health authority inspections.

Skills

Project management

Organizational skills

Planning skills

Knowledge of GMP

Familiarity with HSE

Education

Bachelor’s or Master’s Degree in related field

Job description

About Novartis

Novartis is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies in the world, known for its focus on research and development in various therapeutic areas including oncology, cardiology, immunology, and neuroscience. Novartis produces a wide range of pharmaceuticals, including prescription drugs, generic drugs, vaccines, and over-the-counter medications. The company also has divisions dedicated to eye care and generic medicines. Novartis is recognized for its innovative drugs and contributions to healthcare globally.

Job Opening: Quality Manager – TRD

Job Description

Summary: We are seeking a Quality Manager for our TRD (Technical Research and Development) team. The ideal candidate will provide quality assurance with a focus on IT systems, offering guidance and support to operational activities within our development and research organizations. This role ensures compliance with applicable regulatory requirements, Novartis procedures, and quality standards. The Quality Manager will manage projects, including Quality Plan initiatives, and processes to support quality objectives and ensure compliance with GxP regulations.

Key Responsibilities:

• TRD QA Manager as Business System Owner: Oversee the development, maintenance, integration, and operation of GXP-validated IT systems.
• System Enhancements: Document, test, and implement operational requirements according to IT Waterfall Methodology.
• Compliance and Security: Ensure the system and data security comply with Information Security and Compliance requirements.
• System Upgrades: Identify and implement IT system upgrades to enhance performance and address recurrent application issues and bug fixes.
• Interface Mitigation: Collaborate with other platforms (e.g., SAP, IRT) to address and mitigate interface-level issues.
• Audit Support: Assist with internal audits and health authority inspections.
• Deviation Remediation: Help remediate deviations related to IT systems and monitor associated corrective and preventive actions.
• Validation Reports: Review and approve IT system validation reports.

Candidate Profile

• Education: Bachelor’s or Master’s Degree in a related field.
• Experience:
  • Over 9 years of practical experience in the chemical/pharmaceutical industry or more than 3 years of expertise in the field.
  • Experience in handling IT systems as a Key User, Super User, or System Owner.
  • Knowledge of the drug development process or quality assurance.
• Skills:
  • Basic project management, organizational, and planning skills.
  • Familiarity with relevant regulations (e.g., GMP, HSE) and Novartis-specific standards.

Additional Information

• Experience: 5+ years
• Qualification: B.Pharm, M.Pharm
• Location: Hyderabad
• Industry Type: Pharma/Healthcare/Clinical Research
• Division: Development
• Business Unit: Innovative Medicines

Novartis is committed to building an inclusive, flexible, and diverse workforce culture. Novartis is an equal opportunities employer and welcomes applications from all qualified candidates.