MS&T Specialist

21 hours ago

Hyderabad Secunderabad Telangana, India beBeeValidation Full time ₹ 15,00,000 - ₹ 28,00,000
Job Description:

As a Validation and Life Cycle Management Expert, you will be responsible for ensuring that site validation programs meet global regulatory expectations.

  • Prepare process and cleaning validation documentation, as well as change evaluations, and execute change tasks to meet cGMP requirements on time and with quality.
  • Support process validation lifecycle activities and create local templates for the respective validation documentation.
  • Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
  • Provide technical expertise and facilitate the creation of a quality risk assessment.
  • Have a profound background in organic chemistry to support physico-chemical buffer stability risk assessments, evaluation of corrosive agents as part of facility comparability assessments.
  • Prepare 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 preparation 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 generate deviation lists for PPQ batches.
  • Prepare, approve, and life cycle manage 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.
  • Coordinate documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable.
Required Skills and Qualifications:

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.

Benefits:

Quality / Accuracy / Right First Time

Timeliness

Deviations / Escalations

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