Specialist Quality Operations

Year    Hyderabad, Telangana, India

Job Description


About the role

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it\'s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!

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

Major Accountabilities:
Responsible for the evaluation of chemical synthesis routes to identify, categorize and control possible mutagenic impurities in active pharmaceutical ingredients (API) and drug products.
Assessment of potential degradation pathways of APIs in final drug products with the purpose to identify and assess possibility for the formation of potentially mutagenic impurities and ways to prevent this.
Participate in cross- functional technical teams as required to deliver on projects.
Involved in paper- based assessment of toxicological data for mutagenic, genotoxic and nitrosamines
Conduct of feasibility studies for generic API synthesis and synthesis of by-products, degradation products and related substances.
Protection of intellectual property in the field of organic synthesis.
Utilize scientific expertise and chemical database to generate solutions to problems. Maintaining laboratory logbooks and other project documents as per HSE requirements. Co-ordination of laboratory work performed by technicians.
Creation of relevant instructions, protocols and reports in accordance with scientific and regulatory standards.
Implementation of and adherence to all the instructions and requirements for safe work, environment protection and property protection.
Responsibility for personal and professional development, willingness to continuously learn and enhance the knowledge.
Continued education and learning in form of training and mentoring.
High integrity and proactive cooperation within local and global teams across different geographies.If needed, to be trained according to SOPs related to GxP

Role Requirements

Post-Grad degree (MSc) in Chemistry, Pharmacy or other Natural Science degree with proficient program in organic chemistry with 4 year of relevant experience. Excellent theoretical knowledge of Organic chemistry and mechanisms of chemical reactions, advanced knowledge of medicinal chemistry advantageous.
Proven track record as a successful synthetic Organic Chemist and other complex synthetic chemistry experience. Priority will be given to candidates with relevant industrial experience in the field of active pharmaceutical ingredient synthesis and PhD from the field of Organic or Medicinal chemistry.
Proficient in English & Experience of working closely with the global stakeholders.

Functional Area

Quality

Division

SANDOZ

Business Unit

Quality STO

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis

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Job Detail

  • Job Id
    JD3187219
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year