Specialist / Associate Manager - MS&T

3 days ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

- The individual shall have a comprehensive understanding and experience of using Quality Risk management framework and shall possess excellent investigational report writing skills.
- The individual shall have hands-on experience of using structured RCA (Root Cause Analysis) methodologies such as impact assessment, Fish bone diagram, 5 whys, Timeline & process mapping for investigation of deviations.
- Experience in handling Investigations and Deviations related to Process (Upstream / Downstream), Product & Equipment
- Understanding of core manufacturing unit operations such as sampling, monitoring, and continuous process support.
- The individual shall have broad experience working in GxP environment and handling procedural requirements for HA audits.
- The individual will also be responsible for offering technical and scientific expertise to address process-specific matters, ensuring compliance with cGMPs, SOPs (Standard Operating Procedures), and relevant guidelines and functional standards (such as HSE (Health, Safety and Environment) and NOSSCE).
- Prior experience of handling internal and health authority audits and inspections is preferred
- Ensure overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable).
- Certification in investigation handling - Root cause analysis (RCA) is preferred.

Essential Requirements:

- Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
- Min 5 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility
- Minimum of 5 years of pharmaceutical process validation and cleaning validation.
- Should be familiar and able to perform basic statistical evaluations using Minitab or other statistical analysis tools.
- Proficient knowledge on deviation handling, incident investigations, root cause analysis, and CAPA management.
- Knowledge of risk assessment and risk management programs.
- Should be familiar with regulatory guidance on validation, product filing and post approval changes.
- Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistica etc.).
- Good communication, presentation and interpersonal skills.

Desirable Requirements:

- Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.

  • Ms&t expert

    2 weeks ago

    Hyderabad, Telangana, India BeBeeSpecialist Full time

    Job Title: Specialist - MS&T We are seeking a skilled and experienced professional to join our team as a Specialist in Manufacturing Science and Technology (MS&T). This role will be responsible for providing technical support to the manufacturing operations, ensuring compliance with regulatory requirements and optimizing processes to improve efficiency. Key...

  • MS&T Specialist Role

    23 hours ago

    Hyderabad, Telangana, India beBeeExpertise Full time ₹ 75,00,000 - ₹ 1,50,00,000

    MS&T Specialist Role OverviewThe role of MS&T Specialist is crucial in ensuring seamless collaboration between Site MS&T teams and multifunctional technical operations teams within the Large molecules platform. This individual plays a key role in facilitating effective communication, supporting problem-solving activities, and driving process improvements.Key...

  • Ms&t Expert

    3 weeks ago

    Hyderabad, Telangana, India BeBeeSpecialist Full time

    Job Title: Specialist - MS&T We are seeking a skilled and experienced professional to join our team as a Specialist in Manufacturing Science and Technology (MS&T).This role will be responsible for providing technical support to the manufacturing operations, ensuring compliance with regulatory requirements and optimizing processes to improve efficiency.Key...

  • MS&T Expert

    2 weeks ago

    Hyderabad, Telangana, India beBeeSpecialist Full time

    Job Title: Specialist - MS&T We are seeking a skilled and experienced professional to join our team as a Specialist in Manufacturing Science and Technology (MS&T). This role will be responsible for providing technical support to the manufacturing operations, ensuring compliance with regulatory requirements and optimizing processes to improve efficiency. ...

  • Senior MS&T Specialist

    3 days ago

    Hyderabad, Telangana, India beBeeRiskAssessment Full time ₹ 1,80,00,000 - ₹ 2,20,00,000

    Job Title: MS&T SpecialistWe are seeking an experienced MS&T Specialist to join our team. The ideal candidate will possess expertise in Extractable and Leachable (E&L) risk assessment, including the ability to determine risk levels and update risk assessments.About the Role:The successful candidate will be responsible for building a comprehensive material...

  • Specialist - Ms&t

    3 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary The purpose of the Specialist role is to work collaboratively with Site MS&T team and multifunctional technical operations teams in Large molecules platform.The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities.Maintain the oversight on Process and Validation...

  • Specialist - MS&T

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary The purpose of the Specialist role is to work collaboratively with Site MS&T team and multifunctional technical operations teams in Large molecules platform. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. Maintain the oversight on Process and...

  • Specialist - MS&T

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description SummaryThe purpose of the Specialist role is to work collaboratively with Site MS&T team and multifunctional technical operations teams in Large molecules platform. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. Maintain the oversight on Process and Validation...

  • Specialist - MS&T

    4 weeks ago

    Hyderabad, Telangana, India myGwork Full time

    This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Summary The purpose of the Specialist role is to work collaboratively...

  • Specialist - MS&T

    4 days ago

    Hyderabad, Telangana, India Sandoz Full time

    Job DescriptionKey Responsibilities:Extractable and Leachable (E&L) Expertise- Understanding of Extractable and Leachable (E&L) risk assessment for materials based on supplier information and the ability to determine the risk level and update the Risk assessment.- Building a comprehensive material library backed by corresponding E&L test data- Managing the...