Thomas John

* ****** ****, ******, **, *****

Phone: 914-***-****

e-mail: adu8v4@r.postjobfree.com

SUMMARY:

Quality Control Supervisor/ Compliance Specialist/Quality Assurance with successful career producing quality results with high levels of problem solving and decision making in the pharmaceutical industry. Both the internal and external Customer relationships, to communicate, and collaborate across functions to maximize productivity, improve processes, and achieve objectives while maintaining quality standards and industry regulations in a rapidly changing environment.

Areas of expertise include:

• Quality Control/Quality Assurance Operations & Compliance • QA / QC Quality Management• Problem Solving • Instrument Troubleshooting • Process Improvement • Standard Operating Procedures (SOPs) • Compliance and Regulations • Collaboration • Organization • Data Analysis / Reporting • Metrology. Laboratory and Production Investigations/CAPAs in TrackWise Digital. • Stability program • Annual Product Review

EXPERIENCE:

Endo Pharmaceuticals/Strides Pharmaceuticals 09/2014 - Present

QC Supervisor

As a QC investigator responsible for assuring that the Laboratory investigations are conducted in compliance with all cGMP & FDA regulatory as well as corporate requirements.

Responsible for oversight and execution of complex and critical deviations and investigations related to quality control (QC) out of specification (OOS), out of trend (OOT), and/or process failures within the quality control labs.

Conducts, prepares, review and approve of Laboratory investigations, OOS/OOT/deviation.

Participate in investigation root cause analysis and trending, verifying supporting documents and data for accuracy and completeness. Ensures quality assurance and regulatory compliance throughout the laboratory investigation process while adhering to applicable regulatory statute and standards.

Participate in product complaint investigations by scheduling the associated the QC laboratory tests and give the laboratory related investigation details to QA management for the final report.

Maintaining Investigations, CAPA, Deviations and OOS/OOT logs.

Tracking Analyst Error trends.

Conducts training to QC Analysts to minimize the investigations due to Analyst error.

Oversee investigations, CAPAs (Corrective and Preventive action) process with external -Outsource Laboratories and vendors.

Weekly basis, schedule meeting and attending Investigation Review meeting with other departments SMEs to assess status of the investigations, communicate to management of issues for immediate attention.

Provide monthly metrics regarding Investigations and CAPAs.

Work to resolve noncompliance issues with raw materials, finished products and stability products.

As QC Supervisor responsible for QC (Analytical and Microbiological) activities to ensure laboratory activities comply with internal company policies and procedures, regulatory requirements, including data governance to meets company’s quality drugs production goals

According to priority, day to day – assign the laboratory work to QC analysts, review & approve final reports of raw materials, packaging components, raw material reduced testing, bulk in-process batch samples, finished drug products, and Stability products by utilizing Quality management systems such as SAP, Track Wise Digital and Star-LIMS and Laboratory information Management System (LIMS). Effectively communicates with labs analysts/supervisors and managed data integrity for accuracy, consistency, regulatory compliance, and specification and maintained QC Lab quality productivity goal.

Weekly basis, attended meetings with Integrated Production Planning Team, according to forecasts and deadlines to schedule timely testing and release of raw materials, in-process and finished products which met quality and production goals

Review out of specification, out of trends and investigation report, interacted with other departments. Supported and maintained CAPA in the Track-wise Digital. Evaluate data to detect product or method-related trends, generated and maintained metrics and reports reported on monthly basis to present in Quality Review Board (QRB) meeting.

Daily basis, internal cGMP/GDP, safety, and housekeeping walkthrough for QC Laboratory (Analytical & Micro) for continuous improvement which kept labs ready for regulatory inspection.

Initiate, review and update SOPs and monographs of Raw Materials (including reduce testing), Packaging components, finished products and Stability Products.

Prepare and review Calibration reports of QC & Microbiological Labs equipments and approved in LIMS Calibration Manager System.

Initiate, review and approve protocols and final reports for vendor qualification, cleaning validation/verification, Method transfer, Method validation, method verification.

Prepare, review, and approve reports of packaging components and Raw materials. Maintained reduced testing program which helped to achieve cost improvement goals of Raw material lab.

Support and participate to all internal and external corporate audits and response on timely manner.

Participate in required regulated agencies Annual Product Review (APR).

Responsible for weekly internal Laboratories audit for cGXP and Safety.

Participate in audits, customer, internal, external, as well as regulatory inspections

Handle special projects or assignments as directed by Quality Management team

Barr Pharmaceuticals/Teva Pharmaceuticals 12/2007 – 09/2014

QC Supervisor

Responsible for QC (Analytical and Microbiological) activities to ensure laboratory activities comply with internal company policies and procedures, regulatory requirements, including data governance to meets company’s quality drugs production goals

•According to priority, day to day – scheduled the laboratory assignment to QC Analysts, reviewed & approved final reports of raw materials, packaging components, raw material reduced testing, bulk in-process batch samples, finished drug products, batch record and Stability products by utilizing Quality management systems such as SAP, TrackWise and Laboratory information Management System (LIMS).

•Weekly basis, attended meetings with Production Planning Team, for timely testing and release of raw materials, in-process and finished products which met quality and production goals

•Reviewed out of specification, out of trends and deviation/ investigation report, interacted with other departments and customers to address customer comments on Investigation and Deviations on various stages resulted in timely revisions and approvals.

•Evaluated data to detect product or method-related trends, generated and maintained metrics.

•Attended monthly USP/NF meeting and reviewed compendial changes and managed them appropriately before the effective change date.

•Weekly basis attended Change Control meeting and interacted with subject matter expert (SME) team for changes. Initiated change controls in for changes in compendial methods and revisions of controlled documents- SOPs, method, stability protocol, monograph, and specification limits.

•Initiated, reviewed and updated SOPs and monographs of Raw Materials (including reduce testing), Packaging components, finished products and Stability Products in Master Control system which approved and implemented in timely manner.

•Prepared and reviewed Calibration reports of QC & Microbiological Labs equipment/apparatus and approved in Calibration Manager System.

•Responsible for stability programs. Initiated, reviewed Protocols, data, and final reports. Followed-up with third parties on adherence to testing schedules.

•Initiated, reviewed and approved protocols and final reports for vendor qualification. cleaning. Validation/verification, Method transfer, Method validation, method verification which met acceptance criteria, compliance, and adherence to cGMP.

•Prepared, reviewed, and approved reports of packaging components and Raw materials

•Conducts, prepares, review and approve of Laboratory investigations, OOS/OOT/deviation including root cause determination impact assessment.

•Support and participate to all internal and external corporate audits and response on timely manner.

Barr Pharmaceuticals 10/1999 – 12/2007

QC Senior Chemist

Responsible for QC (Analytical and Microbiological) activities to ensure laboratory activities comply with internal company policies and procedures, regulatory requirements, including data governance to meets company’s quality drugs production goals

Conducted assay, impurities, dissolution, content uniformity, moisture, and other physical and chemical tests as necessary for raw materials, intermediates, finished products and stability samples, in a timely manner using HPLC, GC, Moisture analyzer, Karl Fisher, UV/VIS, FTIR, and Malvern Mastersizer Particle Sizer equipments following appropriate analytical procedures.

Followed good documentation practice and document analytical tests on lab notebooks and Laboratory Information Management Systems (LIMS) timely and accurately.

Followed and complied with existing SOPs and recommend improvements and updates with respect to our company’s policies and procedures on quality and safety assurance.

Developed and validated analytical methods; analyze raw materials and in- process/finished product samples using modern quality control techniques like HPLC, UPLC, GC, XRD, UV-Vis and Malvern Master Sizer Particle Sizer.

Reviewed and authorized analytical data to ensure reliable and accurate analytical data generated by lab analysts.

Supported detailed requirements for Laboratory Information Management system (LIMS) builds, building, testing, and managing its Master Data changes.

Wrote protocols in support for process Validating batches and method transfer. Participated in development, validation, and transfer of methods for new raw materials, intermediates, and finished products as well as the activities and procedures which are required to sample and test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions.

Performed troubleshooting of laboratory instruments.

Performed calibration of laboratory instruments (HPLC, GC, Malvern Particle Sizer) as per calibration SOP procedure.

Participated in out of specification and failure investigations and recommended corrective and preventive actions and demonstrated problem solving abilities.

Trained junior colleges and developed training plans and/or oversee training activities for groups.

Barr Pharmaceuticals 09/1995 – 09/1999

QA Associate

Responsible for QA activities to ensure Drug Product manufacturing is in comply with internal company policies and procedures, regulatory requirements.

Provided quality oversight of all manufacturing operations including line clearance, in-process inspections, label inspections and control, raw material release, environmental monitoring, and sample retention.

Performed GMP inspections and attribute inspections of materials, intermediates, and product according to the batch record, packaging record, specifications, and procedures.

Monitored all aspects of manufacturing, processing, and packaging operations, documenting inspection results by completing records and logs as required by procedures.

Performed Master and Batch Production Records Review (Aseptic Manufacturing).

Maintained safe and healthy work environment by following written standards and procedures, complying with applicable regulatory requirements.

Escalated potential issues and concerns immediately to QA and Operations management.

Approved printed documents for materials prior to use on the manufacturing floor.

Real time review of all documentation and reporting in support of process unit operations.

Supported material release for drug product manufacturing.

Supported non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.

Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Organization of Document Control room and preparation of completed Batch Records documents retransfers QA Document Control and Archival.

Monitored warehouse, manufacturing, and manufacturing support activities for CGMP compliance through spot checks/internal audits.

Participated in writing, review and approve standard operating procedures.

EDUCATION:

Bachelor of Science (B.S) in Chemical Engineering,

Manhattan College, Riverdale, New York

1991-1995

Master of Science (M.S) in Analytical Chemistry

Mahatma Gandhi University, Kerala, India

1984-1986

Reference: Available upon request

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