SAHIL SHAH

Managing pharmaceutical projects for EU market at development phase (product development, technology transfer, BE study, filing) as per the shared goals to meet the timelines and within the budget, while working closely with different internal stakeholders from PD, RA, Commercial & external stakeholders of CDMO/CMO/CRO.

• Circulate the Project Initiation Form (PIF) to various stakeholders for sign-off upon identification of a project for EU region.
• Upon PIF sign-off, work on planning development, registration, launch, or market acquisition and tech-transfer projects (including timelines and budget) in PWA (Project Web App).
• Design a project plan in accordance with business goals and objectives as well as integrate it with QMS.
• Coordinate with QA team for integration of all the QA aspects into the project management, which includes supplier qualifications, QTA, audit reports, customer qualifications, MIA, WDA, etc.
• Coordinate with external CROs and CMOs to ensure that the QMS requirements are met.
• Coordinate with RA/QA for raising necessary registration change controls in QMS.
• Request RP for project launch form (FOR 0023) providing the necessary details for the project once the dossier has been submitted for MA approval.
• Coordinate with concerned stakeholders for getting the product launch form signed according to SOP 0019 for New Product Launch. Organize meetings with CROs/CMOs and internal stakeholders to discuss project plans and ensure that the targeted timelines are met. Monitor the variance in project timelines and budget and proactively raise a flag to management wherever required.
• Upon successful completion of the project, circulate a Project Closure Form to all stakeholders for handing over the project to the commercial and life-cycle management team.
• Focus on the learnings from a project to implement better risk mitigation strategies for upcoming projects and emphasize it to all the Cross-Functional Teams.

Managing pharmaceutical projects for different markets (such as UK, CAN, AUS, MENA, etc.) at development phase (product development, technology transfer, BE study, filing) as per the shared goals to meet the timelines and within the budget, while working closely with different internal stakeholders from PD, RA, Commercial & external stakeholders of CDMO/CMO/CRO.

• Circulate the Project Initiation Form (PIF) to various stakeholders for sign-off upon identification of a project for EU region.
• Upon PIF sign-off, work on planning development, registration, launch, or market acquisition and tech-transfer projects (including timelines and budget) in PWA (Project Web App).
• Design a project plan in accordance with business goals and objectives as well as integrate it with QMS.
• Coordinate with QA team for integration of all the QA aspects into the project management, which includes supplier qualifications, QTA, audit reports, customer qualifications, MIA, WDA, etc.
• Coordinate with external CROs and CMOs to ensure that the QMS requirements are met.
• Coordinate with RA/QA for raising necessary registration change controls in QMS.
• Request RP for project launch form (FOR 0023) providing the necessary details for the project once the dossier has been submitted for MA approval.
• Coordinate with concerned stakeholders for getting the product launch form signed according to SOP 0019 for New Product Launch.
  Organize meetings with CROs/CMOs and internal stakeholders to discuss project plans and ensure that the targeted timelines are met.
  Monitor the variance in project timelines and budget and proactively raise a flag to management wherever required.
• Upon successful completion of the project, circulate a Project Closure Form to all stakeholders for handing over the project to the commercial and life-cycle management team.
• Focus on the learnings from a project to implement better risk mitigation strategies for upcoming projects and emphasize it to all the Cross-Functional Teams.

Managing pharmaceutical projects of India and other regulated markets (US/OAM) from initiation to end, at different stages such as product development, technology transfer, filing, approval and launch, as per the shared goals to meet the timelines and within the budget, while working closely with the different stakeholders from BD, IPR, SCM, FDD, ADD, PMD, CPP, RA, DQA, MSTG, Production, Packaging, QC, QA, Warehouse, and so on.

• Preparing project charter
• Imparting project kick off session
• Planning, monitoring, controlling projects w.r.t. timeline and budget
• Communicating a detailed project plan with all the key stakeholders to mention the project tasks, timelines & responsibilities and coordinating effectively to ensure timely project delivery
• Regular weekly, monthly & quarterly meetings with the key stakeholders, project leaders and management to provide an accurate project updates through presentations
• Working directly with the team members and leaders to estimate challenges, team efforts required in the project and plan activities accordingly to meet the project delivery timelines
• Facilitating discussions and managing conflicts in a way to bring about the solution and agreement between stakeholders
• Identifying project risks and managing through risk mitigation plans
• Ensuring project requirements are fulfilled at right time and right place to plan activities and avoid delays – e.g. development demands from FDD/PMD/ADD, plant batch demands, validation demands, bio & clinical demands, filing demands, launch demands, and so on.
• Envisioning and forestalling possible delays and analyzing to have CAPA in place
• Following escalation matrix to handle any open, unclear and unanswered project issues and ascertain timely delivery of the project
• Continuous learning the project management systems and skills required to ensure implementation during ongoing and upcoming projects

Strengthening quality system in FR&D-non orals, packaging & device development departments to meet current and upcoming regulatory expectations and challenges as continuous improvement.

Preparing, reviewing and approving SOPs, guidelines and checklists as per current regulatory requirements and gap assessment of global quality standards.

• Reviewing and approving of documents related to formulation, packaging & device and analytical development effectively with quality inputs and within timeline
• Development study protocols and reports such as compatibility with product contact parts like SS316L/glass/filters/tubes, pH stability, temperature cycling, photo stability, tenability, reconstitution/admixture/in-use, other formulation/product specific studies, and, so on
• Packaging development documents such as pack evaluation report, pack proposal, transportation studies.
• Device development documents such as device functionality studies, A-FMEA, device history file, drug-device combination products - threshold analysis and use related risk assessment
• Analytical development documents such as extractable (generic/simulation) and leachable study protocols and reports
• Technology transfer documents such as master formula, master packaging card, risk assessment based on QbD, failure mode effects analysis, scale up report, safety data sheet, stability study plan for submission batches
• Filter selection and validation documents such as FTQ form, filterability report, PPQ form, filter validation protocol and report, TDI letter
• Investigation and justification reports for plant submission
• Controlled correspondence and scientific advice to regulatory agency
• Pharmaceutical development reports (QbD) for different regulated markets like US/EU/CAN/NZ/AU/Japan/China, India and Emerging markets
• Risk assessment reports w.r.t elemental impurities & nitrosamine impurities in drug product, extractable from product contact parts and process components such as tubes/filters, container closure system, leachable from drug product, residual solvent declarations, and, so on
• Specifications of raw materials, packaging materials, in process and finished products
• Query responses to different regulatory agencies
• Process capability reports to evaluate product robustness
• Stage gate presentations at different stage of product development such as scale up, exhibit and filing stage
• Laboratory notebooks and analytical COAs to ensure correctness and reliability of experiments data

Conducting internal audits as per the schedule to ensure compliance in FR&D-non orals, packaging & device development department labs/areas.

Conducting training on SOPs/guidelines in FR&D-non orals, packaging & device development departments as per the plan and ensuring its effectiveness.

Reviewing QMS documents such as change control, deviation and CAPA effectively and timely through 'Track-wise' module and ensure quality system compliance.

Reviewing calibration and qualification documents of equipment/instruments of FR&D-non orals, packaging & device development departments effectively as per the plan.

SPOC for the following activities.

• Engaging in Electronic documentation IT enablement projects such as ELN, EDMS, EDAMS and Laser-fiche
• Tracking filter validation activity
• Tracking projects at different stages such as development, scale up, exhibit and filing stage
• Updating product filing, launch, approval status
• Functional training coordinator for PEDAL/external training
• Delivering development presentation in HR Induction Program PRAVESH to new joiners
• Updating monthly report for management review

Managed documents control like Issuance, archival, retrieval and disposal of documents such as SOPs, STPS, GTPs, specifications, BMR, BPR, logbooks, laboratory notebooks and other related documents.

Engaged in in-process QA activities.

• Line clearance of area before starting of dispensing, manufacturing and packaging activities
• Swab sampling for cleaning verification and sampling of finished products & retention samples
• Weekly GMP walk in pilot plant, formulation & analytical lab, engineering, warehouse

Engaged in review of documents within timeline with quality inputs.

• Batch records – BMR/BPR, product development reports
• Analytical documents such as specifications, STPs, stability data, COAs, method validation protocols & reports
• Calibration and qualification certificates of manufacturing equipment, analytical instruments and utilities
• Equipment/Instruments URS, DQ, IQ, OQ, PQ documents.

Engaged in batch release of clinical samples after satisfactory review of batch records, analysis records, certificate of analysis and certificate of conformance by QP.

Engaged in audit preparedness and compliance verification activities related to internal audit, client audit and regulatory audit as per audit agenda.

Conducted and Coordinated training for new joiners and timely updated all the training records in the 'eTraining' module.

Managed tracking of QMS documents such as deviation, change control and CAPA through 'Track-wise' and OOS/OOT and market complaint investigation registers.

Engaged in preparation and tracking of following documents.

• SOPs and guidelines related to quality system through 'e-DMS'.
• Annual trends of deviation, change control, CAPA, OOS, market complaint.
• Quarterly water and environment monitoring trend.
• Monthly MIS report for submit to management.