Snehkumar Panchal
Flemington,NJ
Summary
Results-driven Associate Director known for high productivity and efficient task completion. Skilled in strategic planning, team leadership, and project management. Excel at communication, problem-solving, and adaptability, ensuring successful outcomes in fast-paced environments. Harness these soft skills to lead teams effectively toward organizational goals.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Associate Director, Quality Operations
Halo Pharmaceuticals
Whippany, NJ
08.2022 - Current
- Leading quality operations with around 40-plus clients by streamlining client and agency requirements.
- Practice continues risk assessment and attains improvement measures by establishing or modifying strategic QMS controls and oversight over GMP operations, adhering to ICH and ISO standards.
- System Owner for Quality System Elements, including but not limited to Regulatory and third-party Client Audits, Deviations, Complaints, CAPA systems, Change Controls, Documents, and in-process controls.
- Provide strategic compliance solutions in GMP operational and development work for clients, i.e., clinical, product developmental, and commercial.
- Point of quality contact for design and facility establishment for sterile injectables.
- Re-defined handling of changes by assessing user roles in the system and restructuring them, reconfiguring the change control system in Trackwise, identifying and reassigning user roles and privileges, and revising procedures and comprehensive training, resulting in a 98% reduction in past due items and 100% visibility on each change being implemented based on criticality and business impact.
- Introduced an interim impact assessment and effectiveness check of change implementation aligned with Q10.
- Brought 100% visibility over the health of the site’s change control system through weekly compliance meetings.
- An average TAT for change implementation improved by 78% in two quarters.
- Cultivation of entire investigation/deviation system in totality by introducing triage and IRB to establish uptake and initiation of deviation/investigation, instituting a matrix to determine criticality based on CDMO/CMO business model and nature of event, identifying SBOs from value streams and laboratory and training, introducing immediate impact assessment segment to isolate and bracket the scope and impact aiding into on-time closure and disposition, reconfiguring handling of investigations/deviations in Trackwise.
- Efforts like this resulted in an 80% reduction in human error and training inefficiency.
- Slowly eliminated planned deviations from the QMS by addressing frequently deviated QSEs outside of deviation management, i.e., the conditional release and temporary changes module in Trackwise.
- Vigorous brainstorming, triage, and involvement in investigation closure instituted a simplified understanding of correction, corrective, and preventive actions.
- With business impact in mind, the introduction of long-term and short-term CAPA, with subsequent impact assessment embedded in the electronic QMS, led to a 34% reduction in overall CAPA initiation and improved effective CAPA closure.
- System owner for the document lifecycle and review process.
- Batch record issuance, execution review, and disposition simplification, with the help of the A3 dashboard, resulted in the consolidation of project and process requirements upfront, avoiding any risk downstream, reducing TAT for issuance, and effective CPP review, leading to a reduction in disposition TAT by 43%. Categorizing errors and placing them in a client-specific dashboard led to an impressive RFT of 94.5%.
- Instituted a program to train a cross-functional team to create an agile and lean workforce.
- Designed and instituted Quality System Elements by the System Based Owner program (QSE by SBO) to foster continuous risk assessment, FDA readiness, personal development, 100% visibility, and accountability for each QSE.
- Process improvements due to risk assessment as part of QSE by SBO are the institution of impact assessment by quality in the work order system, the launched business continuity and contingency plan, and the escalation process for the site leadership team to perform proactive risk assessment, with visibility on the end-to-end process.
- Supported revenue within QMS by creating a tool for Quarantine Shipment, contributing up to 0.9% revenue, formalizing and creating a tool to address impromptu internal/external requests in QMS to enable risk assessment, and driving it under QMS to bring efficiencies and visibility. Introduced a client-centric Material Review Board to identify and eliminate redundancies in material management.
- Quality point of contact to harmonize document and training systems in MasterControl.
- Quality system-based owner for Part 11 compliance for laboratory and manufacturing assets.
- Instituted Part 11 assessment embedded in the modified module of the change control system.
- Hosted successful client audits and regulatory agencies, including the FDA and ANVISA.
- Performed audits for contract laboratories.
- Integration of QSE by SBO and the FDA readiness program, with continuous risk assessment and registering process improvements.
- Integration of the work order system with risk assessment and trending.
- Promote and practice continuous improvements in the Quality Management area through continuous risk assessment and effective quality tool implementation (ISO 9001, ICH Q9, and Q10).
- SME for quality compliance for the upcoming sterile-injectable line.
- Overseeing facilities, controls, design, and processes.
Quality Manager, QMS
KVk Tech, INC.
Newtown, PA
04.2021 - 08.2022
- Leading the QMS team to remediate and attain improvement measures under the warning letter environment.
- Point of contact for Quality for remediation updates to the Agency.
- Working with consultants to address quality gaps and bring enhancements.
- System owner overseeing QMS regurs related to warning letters and 483s.
- Liaison to consultant(s) in modifying critical Quality Management Systems-related changes, such as redefining the Quality unit, management escalation, and regulation/standards visibility.
- Alignment of Quality Management roles and responsibilities (ISO 9001, ICH Q10), shaping Change Control systems with emphasized effectiveness checks, strong oversight over effective writing, and on-time closure of Investigation/CAPA systems, 100% on-time completion for Training, and an effective Audit Program, and instituting ALCOA plus for improved GDP.
- Establishing and modifying 21 CFR Part 11 compliance by creating and revising policies, procedures, and guidance documents for laboratory and manufacturing instruments.
- Quality subject matter expert in reviewing, approving, and implementing part 11 protocols with continuous risk assessment for sustained state of part 11 compliance.
- Collaborating with Computer System Validation (CSV) and Information Technology (IT) departments to execute protocols for periodic verification of backed-up data for lab, manufacturing instruments, and software applications used for manufacturing purposes.
- Responsible for recall/field alert reporting, i.e., initial, follow-up, and final; handled Class I and II recalls.
- Retrospective assessment and review of executed changes, deviations, CAPAs, and performance of risk assessment and mitigation.
- Chaired Quality Review Board, Change, and Investigation Review Boards.
Investigation Specialist
Amneal Pharmaceuticals
Piscataway, New Jersey
12.2018 - 04.2021
- Leading the manufacturing deviations and investigations, laboratory OOS, and technical complaints, including overall CAPA responsibilities.
- System owner for investigations, CAPA, including quality, and ADE complaints for developmental and commercial products, for drug products, drug/device combinations, and medical device operations.
- Establishing, modifying, and harmonizing Quality System Requirements and QMS tools for complaints uptake, investigations, and agency-related reporting requirements.
- This involves building processes, practices, and training controls, including modifying electronic QMS modules.
- To initiate, review, and conduct laboratory investigations for non-conformances and OOS events for commercial and R&D projects with appropriate CAPA proposals.
- To prepare, present, and manage quality matrices for QMS across all product portfolios.
- Overseeing trends for all dosage forms for investigations, complaints, OOSs, and events.
- To initiate and perform an investigation for identified trend(s) to mitigate future implications (Stage-III validation).
- Quality System owner for transitioning manual investigations and complaints into an electronic QMS.
- Managing and overseeing annual product review and Stage-III validation system elements.
Supervisor, Quality Assurance
Amneal Pharmaceuticals
Piscataway, New Jersey
01.2016 - 12.2018
- Contributing to bring the best of in-built quality by ensuring quality in personnel, processes, equipment, utilities, documentation, materials, and other attributes of GMP.
- To supervise, allocate, and plan QA activities in topical, transdermal, oral solid (potent), inhalation, and medical devices operations on and off the production floor.
- To look after personnel and material flow throughout the facility, comprising different dosage forms, i.e., hormonal suites (female/male), topical, transdermal, combination, and medical devices.
- Not only sustained, but also improved the quality on the shop GMP floor by practicing and producing built-in quality products through rigorous quality training, creating robust standard procedures, and strict quality control tools with the help of continuous risk assessments.
- To prepare SOPs, protocols, review and approve calibration reports, qualification protocols, process studies, performance qualification protocols, and cleaning validation protocols.
- To initiate and perform planned or unplanned deviations, out-of-specification and quality complaint investigations.
- To review and approve equipment qualification protocols for complex equipment trials, i.e., transdermal (hydrogel/matrix).
- To initiate, review, and implement temporary changes (change controls) into QUMAS.
- To maintain and achieve proper QA functionality in various complex dosage forms through handling, establishing sampling procedures, and executing environmental controls, in-process and finished product sampling reflects updated standards and guidelines.
- To plan, attend production planning, and other forthcoming project kickoff meetings to discuss the project path to assure the QA role efficiently.
- To provide cross-functional training among floor QA staff for effective coverage.
Quality Assurance Auditor
Amneal Pharmaceuticals
Piscataway, New Jersey
07.2015 - 01.2016
- To review and release master production manufacturing and packaging records for different complex dosage forms, i.e. Transdermal, topical, hormonal, oral solid, injectable, and update the JDE system for uniform disposition of release batches.
- Overseeing GDP across operations, instituting tools and processes for improved RFT, and educating value streams to minimize errors, reduce downtime, and ensure effective turnaround time for review and disposition.
- To review and release labeling components, maintain inventory, and dispense/update in the JDE system.
- To review calibration/qualification protocols, and approve cleaning verification/validation reports.
- To organize a weekly meeting to discuss minimizing errors and for better control over batch record execution.
Annual Product Review Coordinator (QMS - Investigation System)
Amneal Pharmaceuticals
Piscataway, New Jersey
05.2014 - 07.2015
- To establish and achieve process control utilizing trend analysis through APR reports, Stage III validation for all New Jersey-based facilities that include solid dosage forms, liquid dosage forms, topical, and hormonal products.
- To implement FDA and EU guidelines to establish a uniform APR system for the global market.
- Independent contributor SOP preparation for enhanced process control.
- To prepare Continued Process Verification protocols to determine critical process parameters to achieve uniformity in process control, partnering with the technical service department.
- Extensive coordination with cross-functions to implement the Stage III Validation process to reduce the reporting of OOS, unplanned deviations, and quality complaints, establishing tools and procedures.
- Preparation of quality metrics and trend reports exclusively in a timely manner to generate a database to keep track of and utilize them as tools in improving the Quality Management System.
- Provide outlines and input through QMS Metrics, utilizing tools such as QUMAS and Microsoft Office on a regular basis to improve written procedures, and establish a system relevant to the investigation system to cease the suitable procedure globally.
- To present a quality management matrix for all facilities to the Senior Vice President and to track the status of all KPIs (investigations, complaints, audits, risk management, GMP training).
Senior QA- Inspector
Amneal Pharmaceuticals
Branchburg, NJ
03.2012 - 05.2014
- Change Control Coordination: Initiation, Assessment, Approval, Implementation, and Closing process.
- Organize weekly meetings for proposed changes.
- Lead the process improvement meeting for changes pertaining to processes, methods, and specifications, MPR.
- Complaint handling: batch record review and retention sample examination, complaint investigation activities, and report preparation.
- Established complaints data sheets to identify critical complaints to minimize the recurrence.
- Assisting in initiating DCN, CAPA, and performing preliminary manufacturing investigation activities.
- Validation: Prepared Process Performance Qualification Protocol, Cleaning Validation Protocol, Process Study Protocol, and lead the QA team to execute protocols for liquid dosage products.
- Executed validation projects pertaining to cleaning and process validation.
- Calculated the acceptance criteria for cleaning validation using the Therapeutic Dose Method, Toxicity Method, and Maximum Allowable Carryover.
- Extensive assistance in the preparation of the Validation Master Plan and coordination with the support team establish the validation status.
- Production Floor Activities: Manufacturing and Packaging Line Clearance and Approval.
- Assurance of cGMP in operational premises.
- Performing in-process batch record review, logbook review, in-process checks, bulk and finished product sampling, and reconciliation.
- Issuance of labeling material and inventory management.
- Monitoring and performing DI water sampling in strict cGMP.
- Temperature and humidity of stability chamber, warehouse, and DEA-controlled refrigerator storage rooms monitoring.
- Cleaning verification and validation, swab sampling, microbial swab sampling.
- Environmental Monitoring: Collection of air samples in different conditions of manufacturing and packaging operations.
- Effective retention program and monthly visual inspection.
- Stability: Managing the program including initiation, Loading and Pull-out stability samples and submission.
QA – Validation Associate
US Pharma Laboratory
North Brunswick, New Jersey
03.2011 - 03.2012
- Looking after the Raw Material department: Receiving, Sampling, Releasing, Retesting, Documentation, and Vendor Qualification.
- Batch record review and raw material inventory management.
- Raw material allocation.
- Validation (Technical Service) Responsibilities: Calibration of scales and balances, and troubleshooting.
- Equipment qualification and protocol preparation includes the preparation and performance of IQ, OQ, manual preparation, and SOP preparation for equipment such as the water system, TOC analyzer, coating machines, and packaging line equipment.
- Handling outside vendor calibration and qualification, and record keeping, assurance, and verification on preventive maintenance of equipment by outside vendors.
- Asset management.
- Documentation control: Proper record-keeping for all facility documents.
- Association with the QA Director for federal agencies, inspections, and frequent customer audits as well.
Education
Master of Science - Pharmaceutical Manufacturing, Pharmaceutical Manufacturing Practices
Stevens Institute of Technology
Hoboken, NJ12.2010
Bachelor of Science - Pharmacy
North Maharashtra University
Maharashtra India12.2007
Skills
- Quality management and compliance
- Risk assessment and control
- Documentation and audit preparation
- Client relationship management
- Continuous improvement strategies
- Process optimization techniques
- Leadership and strategic planning
- Critical thinking and problem solving
- FDA readiness and quality remediation
- Certified investigation and auditing
- Trackwise, Master Control, SAP proficiency
- LIMS, Syspro, Asset Manager expertise
- Batch Master and QUMAS knowledge
References
Available upon Request.
Certification
- Certified Auditor
- Certified Investigator
References
References available upon request.
Timeline
Associate Director, Quality Operations
Halo Pharmaceuticals
08.2022 - Current
Quality Manager, QMS
KVk Tech, INC.
04.2021 - 08.2022
Investigation Specialist
Amneal Pharmaceuticals
12.2018 - 04.2021
Supervisor, Quality Assurance
Amneal Pharmaceuticals
01.2016 - 12.2018
Quality Assurance Auditor
Amneal Pharmaceuticals
07.2015 - 01.2016
Annual Product Review Coordinator (QMS - Investigation System)
Amneal Pharmaceuticals
05.2014 - 07.2015
Senior QA- Inspector
Amneal Pharmaceuticals
03.2012 - 05.2014
QA – Validation Associate
US Pharma Laboratory
03.2011 - 03.2012
Master of Science - Pharmaceutical Manufacturing, Pharmaceutical Manufacturing Practices
Stevens Institute of Technology
Bachelor of Science - Pharmacy
North Maharashtra University