Talat Behzad

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

518-***-**** ad13a9@r.postjobfree.com

SUMMARY

Accomplished Project Management professional with expertise in DEA Compliance for pharmaceutical & Healthcare organizations in cGMP environment.

Proven track record of driving exceptional results on high-profile, multi-million-dollar projects.

Continuously improved processes and resolve complex issues by interpretation of DEA regulations and developed methodologies to increase efficiencies.

Excellent communicator who effectively conveys complex information to management, DEA, FDA, EPA, and other local regulators in a matrix cross-functional environment.

EXPERIENCE

Sr. manager dea & ehs compliance, granules PHARMA, AUG2023-present

Developed compliance policy and procedure of the Controlled Substance for the business operations at Granules Pharma three different sites in VA.

Managed the newly built packaging facility for the CS packaging unit at VA for DEA, State, & EHS compliance.

Managed the Controlled Substance & Safety department on all day-to-day operation to keep the organization under regulatory compliant.

Monitor and manage the inventory for all controlled substance materials on site for production, packaging, and disposal.

Managed CS record keeping and reporting through hardcopy and electronically.

Monitor and analyze the Compilation of Purchases, Receiving, and Shipping paperwork.

Guided and advised to all departments to ensure compliance with DEA, State, EPA, and OSHA regulations and procedures.

Developed the auditing and monitoring process of the controlled substance to ensure readiness for inspection by regulatory authority. This include keeping and tracking of records of the receipt, storage, manufacturing, packaging, distribution, and disposal of controlled substances through Reverse Distributor.

Managed Import/Export and quota of controlled substance for the business operation.

Oversee and maintain all security measures including Vault, Cage, Safes, Cameras, Motion Sensors, Door locks, Alarm Systems, Card Access System, Lock systems, Gates, and cage Fencing.

Conducted SOP’s, review and monitor training for all departments related to Controlled Substances and Security.

Review internal investigations and recommend corrective actions and ensure that the trainings are imparted as required.

Lead contact in collaborating with Federal and State agencies on the issues relating to reporting requirements, inspections, quota, import, export, and other requests.

Review and submit reports to DEA, State Agencies (Nj, NY, MA, and VA) and other regulatory authorities to resolve questions and concerns.

Hands on experience in pharmaceutical procedure implementation, Good Manufacturing and Laboratory Practices, and current DEA regulatory standards (21 CFR Part 1300 to end).

Plan, organize, and work to solve complex problems and respond to agency requests in timely fashion.

Resolved internal issues in collaboration with others to ensure that the business is in regulatory compliance.

controlled substance manager, psychogenic inc, june2022 -Aug, 2023

Managing and coordinating all DEA (Schedule I-V) related activities at PGI.

Developed controlled substances policy & procedure and its enforcement.

Conduct monthly spot checks, year end, and biennial inventory. Prepare reports for VP of

Quality Assurance and Sr. Director EHS.

Coordinated efforts for animal ordering and IACUC audit.

Oversee perpetual inventory of controlled substances from procurement to waste removal by

reverse distributor. Implements and upholds safety and security procedures. Coordinate all

movement and chain of custody transfers for all control substances throughout site in

database.

Ensure clear and efficient methods for maintaining accountability of all controlled substances

are being developed and implemented.

Assist with the submission of DEA import permits and use applications.

Review and develop policies and procedures relating to controlled substance compliance.

Engaged VP Quality Assurance and Principal Investigators in the procurement and importation

of controlled substances.

Ensure sufficient inventory is available to meet daily research operations.

Maintains a state of inspection readiness throughout all controlled substance compliance

activities.

Dispensing of controlled substance to researchers to meet in-house orders in support of research,

measuring, labeling, and maintaining up to date dispensing records.

Providing training to new employees on controlled substance procedures and confirm verification of

completion of required training and background checks prior to providing controlled

substance privileges. Ensure that staff with access to controlled substance are properly trained to handle and maintain accurate controlled substance records in database.

Schedule waste pick-ups and prepare all required documentation for the controlled substance

waste destruction with Reverse Distributor.

Support inventory accountability and reconciliation for all controlled substances.

Interface with regulatory Inspectors such as DEA for site visits and unannounced inspections.

DEA Compliance Specialist, Lyndra Therapeutics Inc, Dec 2021- June 2022

Executed a plan for development of additional policies, SOPs, guidance, etc. based on prioritized needs in coordination with the Chief Compliance Officer and the heads of impacted departments.

Act as the point of contact for all compliance-related issues specific to the relevant business units.

Developed and executed a plan for ensuring compliance with federal and state requirements.

Assisted in the development and roll-out of Compliance training to relevant departments.

Assisted in investigating the applicable business when there is a suspected violation.

Executed monitoring program to ensure DEA compliance. Monitored and executed DEA 222 Form.

Review metrics with business unit leaders to assist in raising awareness and remediate gaps in compliance.

Managed the development of the Compliance Monitoring program for the Regulatory & Compliance division.

Managed ARCOS reporting and developed internal audit for the readiness of DEA audit/inspection.

Hands on experience in pharmaceutical procedure implementation, Good Manufacturing and Laboratory Practices, and current DEA regulatory standards (21 CFR Part 130.71 to 1301.76).

RELIABILITY ANALYST, General Electric, NY, Oct2018- Dec 2021

Delivered savings to customers by increasing response velocity for unplanned downtime, proactively identifying issues to reduce maintenance costs, and ensuring compliant operations.

Assisted in developing and maintaining an effective compliance monitoring plan for NERC policies and procedures at 30+ sites in multiple regulatory regions in North America.

Assisted in conducting compliance reviews, investigations, and audits to assess compliance with NERC/FERC policies.

As a member of 24/7/365 group, monitored substation and wind power generation assets at over 200+ sites in North Americas.

Coordinated Balance of Plant operations with systems and market operators on behalf of customers including scheduling planned and un-planned outages, documenting equipment reliability, and follow-up on recommended actions.

Represented customer wind farm operations compliance to ISO-NE, NYISO, Versant, Tenaska, ComEd, Hydro One, ERCOT, and others.

COMPLIANCE SUPERVISOR, Sun Pharmaceutical, Cranbury, NJ, April,2014 – Oct,2018

Supervised all DEA activities for over a dozen medicines and raw materials used in production to ensure DEA and cGMP compliance.

Participate in daily cross-functional meetings with Manufacturing, QA/QC, material management, and packaging to ensure that all teams are aligned to DEA compliance.

Managed and monitored internal DEA auditing at different business locations.

Monitoring and reconciliation of inventory of controlled substance to ensure DEA compliance at all levels.

Worked with Quality Assurance to develop and streamline DEA training programs to ensure compliance that were in line with DEA regulatory requirements.

Managed controlled substance deviation and its investigations.

Developed and maintained documentation systems as required by DEA and state regulations, including preparation of all regulatory required reports.

Developed and maintained internal accounting and audit systems for DEA regulated products, including conducting and reconciling inventories.

Compile inventory information from various departments to complete DEA reports (ARCOS, import/export, biennial, yearend, etc.) as required by DEA regulations.

Issue, review, separate and distribute DEA 222 forms on monthly basis.

Managed import/export permit requests.

Ensure site compliance with DEA quotas.

Project Management Consultant, Reckon Healthcare Ltd., Sydney, Australia, 2011-2014

Led the on-time and on-budget delivery of startup phase for the Reckon packing plant in Australia that packages healthcare products for various pharmaceuticals for Australia.

Provide regular status updates to C-level management about the execution of projects resulting in high customer satisfaction rating.

Coordinated with the regulatory authorities for the issuance of controlled substance license.

Led a cross-functional team and resolved issues with sourcing, logistics and quality teams.

Implemented compliance standards and processes for supplied material to ensure regulatory compliance.

Manager of Operations, Sky Trading Inc., Downers Grove, IL, 2008-2011

Streamlined the procedure to develop complex Federal and State regulatory reports monthly to keep the company compliant with regulators.

Delivered a 60% sales increase by improving distribution network and increasing outlets from 360 to 600.

Managed and supervised inventory of product line in coordination with warehouse management.

Project Coordinator, Teva Pharmaceutical Industries/Barr Laboratories, Pomona, NY, 2002-2008

Barr Laboratories was acquired by Teva Pharmaceutical Industries in 2008

Fixed DEA compliance, accuracy, and productivity by automating the controlled substance inventory management system.

Coordination with DEA for the procurement, production, and disposal of controlled substance.

Executed a study that determined that there was lack of communication between DEA compliance, QA/QC and production. Obtained commitment for stakeholders and conducted daily cross-functional meetings to track progress and increase visibility of commitments and dependency across functions.

Managed major facility commissioning initiatives of controlled substance operations. Developed & presented monthly operations reports to senior management.

Consistently communicated with production, operations, supply chain, and management to ensure DEA compliance were achieved.

EDUCATION

Preston University, Karachi, Pakistan

Master of Business Administration

University of Karachi, Pakistan

Bachelor of Science, Statistics & Economics (with honors)

ADDITIONAL TRAINING AND SKILLS

Certifications: Project Management for Administrator

World Bank International Project Appraisal & Project Management

Advanced Certificate in Financial Management- Institute of Business Administration

Consultancy Skills Development – US Aid

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