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Quality Assurance

Location:
Elkridge, MD
Salary:
125000
Posted:
September 26, 2018

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Resume:

Shah Muhammad Mohsin Raza

**** **** ****** *****

Elkridge, MD 21075

443-***-****

ac66pj@r.postjobfree.com

Overview

I seek a position in a dynamic organization offering ample opportunities of diversified exposure and career growth.

I have more than nine years of experience working as a Quality Assurance professional for a pharmaceutical company in a cGMP environment. Additionally, I have approximately two years of experience working as a Quality Assurance Executive in a third-party logistics company. My expertise lies in solid dosage, semi-solid dosage, Softgel, packaging, and Aseptic manufacturing. My areas of expertise include:

Solid dosage

Semi-solid dosage

Softgel and liquid dosage

Packaging

Aseptic Manufacturing

Clinical Trial Management (CTM)

Warehousing

Inventory Management

Internal Auditing

Training personnel in SOPs

Stability Management

Education

Master of Science in Engineering Management

University of Maryland, Baltimore County

August, 2016 (Completed)

-Area of specialization: Biochemical Regulatory Engineering

-Relevant coursework:

Regulatory Issues in Biotechnology

Good Manufacturing Practices for Bioprocesses

Quality Control and Quality Assurance for Biotechnology Products

Biotechnology GMP Facility Design, Construction and Validation

Master of Science in Statistics

Department of Statistics, University of Karachi

December, 2006 (Completed)

Bachelor of Science in Mathematics, Physics, and Statistics

University of Karachi

December, 2003 (Completed)

Employment

Scientific Program Manager at National Institute of Health (NIH) [C]

Columbus Technologies and Services, Inc.

Rockville, MD

February, 2016 - Present

Description: Plan, oversee, review, and evaluate audits of cGMP manufacturing facilities, including reviewing of Quality-related documentation, of vaccine manufacturing plants and biopharmaceutical facilities for GMP/GLP compliance. Support will include, but is not limited to:

Review of standard operating procedures (SOPs)

Review of relevant manufacturing batch records

Review of reports/data for out of specification testing results

Review of change control documents related to manufacturing/testing changes

Prepare audit report detailing corrective actions

Follow up on corrective actions and determined acceptability

Responsibilities:

Work products and documents related to planning, overseeing, reviewing and evaluating audits of cGMP manufacturing facilities.

Work products and documents related to authoring/reviewing/editing manufacturing batch records, SOPS, deviation reports, etc. Review and approve executed batch records.

Work products and documents related to reviewing Certificate of Analysis (CoA) of clinical products. Recommend release of the Active Pharmaceutical Ingredient and Drug product for clinical use to designated federal staff.

Work products and documents related to establishing and maintaining a QA program Ensure vendor GMP compliance.

Work products and documents related to preparing oral and written presentations for internal and external programmatic and scientific meetings.

Product Quality Assurance Specialist at National Institute of Health (NIH) [C]

Henry Jackson Foundation (HJF)

Rockville, MD

January, 2016 – February, 2016

Description: Responsible for providing advice on the evaluation and qualification of manufacturers; assisting with assay development and release testing; helping to establish and maintain a Quality Assurance Program; providing regulatory support; and reviewing and reporting on potential vendors and contract manufacturers in the areas of HIV vaccine development for investigational biologic products.

Responsibilities:

Assist in planning, oversight, review and evaluation of audits of cGMP manufacturing facilities, of vaccine manufacturing plants and biopharmaceutical facilities for GMP/GLP compliance including review of quality-related documentation. Areas of support include review of standard operating procedures (SOPs), relevant manufacturing batch records, reports/data for out of specification testing results, and change control documents related to manufacturing/testing changes. Prepare audit report detailing corrective actions and follow up on corrective actions and determined acceptability.

Assist with assay development and release testing. Author/review/edit manufacturing batch records, SOPS, deviation reports, etc. Review and approve executed batch records to ensure that all steps have been performed and verified (when applicable), that all limits and specifications have been met and that the raw materials and solutions have been tested and released. Review Certificate of Analysis (CoA) of clinical product. Recommend release of the Active Pharmaceutical Ingredient and Drug product for clinical use to designated federal staff.

Establish and maintain a Quality Assurance Program. Assure approaches used meet regulatory requirements, minimize business and personnel risks, and are consistent with industry standards. Manage efficient use of available resources and time.

Provide regulatory support by assisting in the preparation and review of Pre-IND materials (Type B Meeting requests with the FDA), IND documents, and clinical hold situations.

Insure GMP compliance by helping to identify, qualify and monitor vendors’ capabilities and qualifications. Prepare an electronic report on vendors/contract manufacturers in the areas of HIV vaccine development and manufacturing for investigational biologic products identifying capabilities and qualifications.

Completes other projects as needed, including HJF-DAIDS assigned tasks such as submission of status reports and attendance at meetings.

Manager, Quality Assurance

Pharmaceutics International Inc. (PII)

Hunt Valley, MD

December, 2014 – December, 2015

Description: Day-to-day management of the Quality Assurance Operations group while maintaining the highest quality drug products, ensuring the safety, identity, strength, purity, and quality that the drug is purported to possess. To uphold, support, and promote quality by ensuring adherence to the overall company business plan.

Responsibilities:

Oversee all daily activities of QA inspector group, provide direction to supervisors, set priorities, and work with QA leadership team to establish performance goals

Ensure compliance to cGMPs and managing area of responsibility while assuring the effective and timely response to the needs of the organization and clients.

Manage the day-to-day operations and ensure that Quality Assurance (QA) and Manufacturing Management is kept informed on all issues in a timely fashion.

Manage, train, counsel, and mentor the Quality Assurance Operations/Inspections Staff and Supervisors.

Develop group goals and assist Supervisors in implementing and achieving goals.

Assist Senior Management in ensuring that all quality systems are developed, implemented, and maintained in accordance with corporate policies and US/International regulatory requirements.

Maintain metrics of group performance and use these metrics to improve the processes, efficiency, and quality of the products and/or systems.

Manage the priorities for direct reports and ensure that duties are:

Completed efficiently, accurately, and on time.

Aligned with departmental priorities

Participate, as required, in the review and approval of controlled documentation.

Ensure appropriate sampling and disposition of raw materials, intermediates, packaging, and labeling components, and finished drug/drug products.

Interface with all internal departments to proactively identify and correct potential non-conformances to minimize or prevent adverse effect of the issues.

Manage interdepartmental communication in key areas of responsibility.

Ensure that the Quality Assurance Inspection/Operations Staff is properly trained according to approved training matrices.

Lead, mentor, and develop Supervisors and Inspector staff. Conduct performance reviews, interviews, and disciplinary actions as required.

Quality Assurance Associate

Pharmaceutics International Inc. (PII)

Hunt Valley, MD

August, 2009 – December, 2014

Description: I ensure the timely and accurate inspection of raw materials, in-process blends, and finished drug product while adhering to the cGMP and ICH guidelines, as well as USP/NF/EP/JP/Health Canada and other regulatory statutes, as written. I also ensure that the day-to-day tasks of the Quality Assurance Unit supports the overall business plan while maintaining the highest quality drug products, ensuring the safety, identity, strength, purity, efficacy, and quality that the drug is purported to possess. Furthermore, I have overseen the aseptic manufacturing process.

Responsibilities:

Perform “Line Clearance” and “Cleaning Verification” for manufacturing and packaging operations per established Standard Operating Procedures (SOPs), Batch/Packaging, and Labeling Records’ requirements.

Perform in-process sampling, inspections, testing, and batch record reviews during manufacturing and packaging operations as per established SOPs and Batch/Packaging and Labeling Records’ requirements.

Perform Acceptable Quality Level (AQL) sampling and testing as required for in-process and finished product.

Participate in the preparation for sampling, actual submission of samples to Quality Control (QC), and disposition of samples for Cleaning Verification.

Perform inspection of cGMP and non-cGMP areas for compliance to policies and procedures as written approved.

Perform daily systems verifications including, but not limited to, recording and reporting of Magnahelic Gauge data and water system data and the disposition of the systems.

Participate in and support Annual Product Reviews (APRs).

Submit product samples for analytical testing as required.

Create storage systems for storage and retrieval of retain samples, as required.

Perform investigational activities and prepare Incident Reports, Investigation Reports, and Planned Deviation Reports, as assigned.

Review quality systems, including policies and procedures, and recommend improvements affecting compliance and efficiencies.

Engage in planning activities to provide for effective support of manufacturing and packaging operations.

Worked on equipment cleaning failure investigation following FDA inspection.

Quality Assurance Executive (QA Site; Health Safety and Environment)

Agility Logistics Private Limited

Karachi, Pakistan

November, 2007 – July, 2009

Description: I was responsible for assuring the quality of different products in the Warehouse. Additionally, I focused on customers’ product quality and worked for Health Safety and Environment (HSE). I was also an active participant in the Quality Assurance External Audit of Procter and Gamble, held in October, 2008 in Karachi.

Responsibilities:

Ensured effective implementation of all SOPs.

Developed of QA SOPs for operational needs and training of staff.

Accurately review, analysis, and recommendation on all QA Audits.

Developmental needs identification & analysis.

Statistical analysis – Operations & Inventory accuracy.

Monitor, coordinate, resolve / escalate issues related to:

-Inventory.

-Safety & Hygiene

-Security

-Training

-Sanitation & Pest Control

-Adherence to Integrated Management System (IMS) Procedures, Work Instructions and Formats

Preparation of reports – Operational quality and Inventory accuracy

Management System (IMS), Health & Safety, Pest Control and Security related issues.

Safety & Security – Enforcement of guidelines & statistical analysis

IMS Interface – Review of IMS Manual defined as per Quality Standards and resolution of Non-Conformity Report (NCR’s)

Quality of OJT to warehouse staff

Reported any amendment to existing guidelines and standard operating procedures.

Reviews operational procedures, systems adherence, and safety & security guidelines and recommends improvements.

Prepared QA Observation Reports.

Safety & Security – Assessment and Analysis

Reported operational inaccuracy and constraints to contractual obligations.

Random Stock Verification of a minimum of 10% in allocated facility

Updated the training identification chart

Assisted the Manager of QA in gathering information and maintaining records.

Imparted counsel and guided the Warehousing staff on Integrated Maintains records of daily tasks.

Thorough knowledge of WMS Exceed.

Provided a daily report to the Manager QA.

Closely followed up on maintenance and accident / incident related issues.

Highlighted discrepancies observed during QA audits.

Training

USA

Certified ISO 9001:2015 Internal Auditor Training from AQS SOLUTIONS a DEKRA Company – August 2018 (Certificate #: QI10472)

Karachi, Pakistan

One-day workshop on Dynamics of Service Quality from Pakistan Society for Quality Management - April 2009 (Certificate #: PSQM/DSQ/A041809-07)

Diploma course in Service Quality Management (HRM Integrated Approach) from The Chartered Institute of Logistics and Transport (CILT) - Jan 09 until March 09 (Certificate #: CILT/DQM/ 009/09).

Skills

Proficient in using Microsoft Word, Excel, and PowerPoint; Kaye Net Lab Watch Monitoring System

Good knowledge of Microsoft Windows XP, Windows 7, Windows 10, and Windows Server 2003

Knowledge of Minitab, Matlab, ITSM, and SAS

Native Urdu speaker with fluency in English

References

To be furnished upon request



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