Specialist- MS&T

Job Description Summary

The Purpose of the Specialist role is having expertise in Extractables and Leachables assessment, work in close collaboration with multiple functions such as MS&T, Supplier management, Regulatory, toxicology, Procurement, Quality and Production. The individual plays a key role in support of Extractable and Leachable activities with a strong focus on data collection, Risk rating, assessments and evaluation.

Job Description

Key Responsibilities:

 

• 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 coordination for Extractables studies or product-specific leachable studies.

• Preparation of E&L Risk assessment, E&L testing Protocol and Report.

• Compile E&L data and provide the information to Toxicologist for assessment.

• Proficient in risk evaluation, decision matrix, Gap Analysis, and outcome on understanding of manufacturing materials.

• Comprehensive knowledge of the chemical and physical properties (leaching tendency) of MOC materials

• Skilled in defining the original risk level, Mitigation factor, and Final risk level as part of the Risk Assessment process.

• Expertise in Extractable studies, their methodologies, analytical strategies, and design

• Expertise in setting the AET (Analytical Evaluation Threshold) and SCT (Safety concern threshold) for extractables and leachables detected during testing.

• Detailed understanding of E&L guidelines (SOPs, Pharmacopoeia and ICH standards)

• Proficient in identifying and assessing the Worst-case material representative approach.

• Collect the material list and data information from development centers and manufacturing sites.

• Active participation in E&L taskforce and network meetings. Also responsible for coordinating with the development, Supply management, QC, and Production department.

 Essential Requirements:

• Preparation of process and cleaning validation documentation (Protocols, reports) as well as change evaluations for new product launches and Life cycle management activities.

• Ensure project tracking documentation/tools are updated according to plan

• Collaborate closely with the development organization (or sending site) for technical transfers and new product launches to ensure knowledge transfer, appropriate control strategies, risk analysis and control, and readiness for commercial process validation

• Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting

• Coordination of documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable

• Preparation, approval and life cycle management of GxP documents

Training

• Own the Training Curriculum for Own Job Profile

Desirable Requirements:

• Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.

• Minimum 5 years of experience in MS&T or in the manufacturing of pharmaceutical Drug substance and Drug Product for Small and Large molecules.

• Should be familiar with regulatory guidance on ICH Q3,Validation, Product filing and Post approval changes.

• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).

• Expertise in reviewing and writing technical reports

• Good communication, Presentation and Interpersonal skills.

• Proficiency in English (oral and written) is required.

Key Performance indicators:

 

• Quality / Accuracy / Right First Time

• Timeliness

• Deviations / Escalations

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

Skills Desired

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure)

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