Novartis is currently seeking a Quality Operations Specialist for its team in Hyderabad. Known for its innovative product pipeline and commitment to groundbreaking medicines, Novartis is an industry leader driven by a diverse and talented workforce.
Position: Specialist, Quality Operations
Job Description:
- Act as a QA technical subject matter expert for CSV processes involving MES, KNEAT, DCS, and various GMP enterprise systems, including manufacturing and laboratory computerized equipment.
- Provide QA oversight for MES qualification activities (URS, IQ, OQ, and qualification tasks) and support the review and approval of related QA documentation, such as SOPs, site deviations, CAPAs, and change control records.
- Demonstrate hands-on experience with MES, KNEAT, and DCS.
- Utilize knowledge of Agile and the 1QEM system.
- Exhibit strong planning, organizational, and time management skills, with a focus on meeting tight deadlines and maintaining attention to detail.
- Show reliability, a strong sense of accountability, and the ability to work both independently and as part of a team.
- Possess strong problem-solving, analytical skills, and competence in leading cross-functional teams within a matrix organizational structure.
Candidate Profile:
- Experience: 3 to 5 years in quality assurance and GMP within the pharmaceutical/biotech industry.
- Education: Minimum of a Bachelor’s degree in a scientific discipline (pharmacy, chemistry, engineering, life sciences); an advanced degree in natural or applied sciences is preferred.
- Skills: Enhanced computer skills and proficiency in English.
Additional Information:
- Location: Hyderabad (Office)
- Industry Type: Pharmaceutical/Healthcare/Clinical Research
- Division: Operations
- Business Unit: Innovative Medicines
- Application Deadline: 30th November 2024