
Specialist- MS&T 04/09/2025
3 weeks ago
Validation and Life Cycle Management Expertise
- Preparation of process and cleaning validation documentation as well as change evaluations, executing change tasks to meet cGMP requirements on time and with quality, ensuring that site validation programs meet global regulatory expectations
- Supporting process validation lifecycle activities
- Creating local templates for the respective validation documentation
- Participating in pre-validation activities and risk assessments to ensure the success of commercial process validation
- Providing technical expertise and facilitating the creation of a quality risk assessment
- Profound background in organic chemistry to support physico-chemical buffer stability risk assessments, evaluation of corrosive agents as part of facility comparability assessments
- Preparation of Nitrosamine, raw material risk assessments and declarations for residual solvents and elemental impurities
- Support in Extractable and Leachable (E&L) risk assessments, gathering E&L data from suppliers, coordinating E&L studies, calculating AET threshold and maintaining accountability for the site during audits
- Support in prepration and updation of Hazard Analysis Critical Control Point (HACCP), Control strategies.
- Support OPV/CPV preparation and assessment of process performance to support site MS&T team.
- Create and update process excursion signals (PES) in the OPV/CPV monitoring system
- 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
- Coordinate prerequisites for PPQ batches (Qualification status, Status of the analytical methods, raw materials, consumables), update of Risk Assessments for Microbio buffer hold validation, and generates deviation lists for PPQ batches
- Preparation, approval and life cycle management of Gxp documents
- 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
Training:
- Own the Training Curriculum for Own Job Profile
Essential Requirements:
- Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
- Min 5 years of experience in MS&T (Process and Cleaning and Transport Validations) or in the manufacturing of pharmaceutical Drug substance in Sterile/Large Molecules platform/facility
- Should be familiar with regulatory guidance on 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, and Knowledge of German is an advantage.
Desirable Requirements:
- Quality / Accuracy / Right First Time
- Timeliness
- Deviations / Escalations
-
Mathematics Tutor
3 weeks ago
Hyderabad, Telangana, India 98thPercentile Full timeAbout Us98thPercentile is a rapidly growing EdTech company offering online, after-school enrichment programs in Math, English, Coding, and Public Speaking for students in the U.S. market. Our mission is to nurture critical thinking, creativity, and problem-solving skills in young learners through engaging and interactive classes.Position: Math TutorWe are...
-
Specialist Cybersecurity
3 weeks ago
Hyderabad, Telangana, India AT&T Full timeJob Summary We are seeking a skilled Delinea Active Directory bridging Operations Specialist The ideal candidate will be responsible for managing and maintaining the Delinea Active Directory bridging privileged access security platform This includes ensuring its continuous operation and optimization The specialist will play an integral role in AT T s...
-
Specialist - MS&T
3 weeks ago
Hyderabad, Telangana, India Sandoz Full timeJob 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...
-
Specialist - Ms&t
3 weeks ago
Hyderabad, Telangana, India Novartis Full timeJob Description Summary The purpose of the investigation and deviation expert role is to work collaboratively with process experts and multifunctional operations teams in the Biologics and/or large molecules platform sites, taking ownership of deviation management for the site.The individual will actively participate in investigations of deviations,...
-
Presales Specialist 04/09/2025
3 weeks ago
Hyderabad, Telangana, India Vaishnaoi Group Full timeCompany DescriptionVaishnaoi Group is a diversified business establishment with a legacy spanning 25 years. The group is involved in various sectors including real estate development, automobile industry, pipe manufacturing, and textile park. Vaishnaoi Group is committed to innovation and growth across all its business ventures, providing opportunities and...
-
Specialist / Associate Manager - MS&T
3 weeks ago
Hyderabad, Telangana, India Sandoz Full timeJob 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,...
-
04/09/2025 Investment Management Trainee
3 weeks ago
Hyderabad, Telangana, India multiply Full timeAbout the jobOur Firmmultiply is a US based hedge fund startupThe OpportunityYou will joining our branch office at Hyderabad (after launch) in the role of Investment Management Trainee, the incumbent will be required to work closely with portfolio management professionals and the investments team .Our Trainee program is designed to cultivate the fundamental...
-
Photographer 04/09/2025
3 weeks ago
Hyderabad, Telangana, India LivSpace Full timeJob DescriptionWe are seeking a skilled and creative Interior Photographer to join our team to capture stunning images of homes completed by Livspace. As an Interior Photographer, you will play a crucial role in showcasing our work to potential clients and highlighting the craftsmanship and design excellence of Livspace projects.- Conduct on-site photo...
-
04/09/2025 Senior Manager
3 weeks ago
Hyderabad, Telangana, India Sandoz Full timeJob DescriptionMajor accountabilities:- Planning and management, gather requirements to develop detailed Project plans and Project estimations to task level.- Proactively assist the Business to identify upcoming conflicts and resource gaps.- Serve as interface with the global and local Brand teams on Project Planning and delivery management.- Leads and...
-
Procurement Specialist 04/09/2025
3 weeks ago
Hyderabad, Telangana, India Regenplastics private limited Full timerecycling industry experience with sourcing of RM and procurement of plant materials