Search suggestions:

hiring immediately
part time
full time
receptionist
office assistant
phlebotomist
marketing
remote
warehouse
remote work from home
part time work from home
driver
work from home
Wichita
United States
Houston
Dallas
Oklahoma City
Aurora
Amarillo
Chicago
Missouri
San Antonio
Tulsa
Kansas City
Des Moines
Waco
Nashville
Apply

GMP Compliance Specialist

GPTECH
$85,000 - $107,321 a year
Remote
2 days ago
GPTech is a global sustainable energy and infrastructure consulting firm passionate about engineering and energizing a sustainable future. We are a close-knit team of highly qualified technical and development professionals dedicated to making a lasting impact for realizing a sustainable future.

Providing comprehensive services for the entire project lifecycle, we deliver solutions to help clients save money, enhance operations, protect the environment, and achieve sustainable impacts. We are a trusted partner for delivering sustainable solutions through ongoing engagement and continuous improvement. GPTech is a signatory to the Global Compact and supports the United Nations Sustainable Development Goals with an emphasis on providing technical support in the areas of Affordable and Clean Energy; Climate Action; Sustainable Cities and Communities; Clean Water and Sanitation; and Industry, Innovation, and Infrastructure.

As a small business, we are proud of our big results. After just 14 years in business, GPTech has successfully supported more than 100 projects for over 30 clients in over 75 countries, with no sign of slowing down. Today, we are one of the world’s leaders in employing innovative energy and engineering solutions to sustainably manage the earth’s resources and meet societal needs. Visit www.greenpwrd.com for more information.

GPTech is seeking an experienced Good Manufacturing Practices (GMP) Compliance Specialist to support a U.S. Development Finance Corporation project in Nepal. The GMP Compliance Specialist will play a critical role in ensuring that the design, construction, and commissioning of the Deurali Janta pharmaceutical manufacturing facility meet international GMP standards, including WHO GMP, EU GMP (EMA), and US FDA cGMP frameworks. Working closely with the project team, the Specialist will provide technical oversight, conduct design reviews, support construction monitoring, and guide the project towards compliance with stringent regulatory expectations for quality, safety, and process integrity.

Key responsibilities include evaluating process safety management, cleanroom design, HVAC zoning, material and personnel flows, and other critical systems (designed by others) to ensure alignment with GMP requirements. The Specialist will review technical documents, participate in site inspections, and confirm that construction and installation meet applicable standards. This is a remote consulting position with periodic work over a 4-year period with occasional travel to Nepal as needed.
Key Responsibilities:
  • Reviewing facility design documents to assess compliance with GMP requirements.
  • Verifying design and construction alignment with EU GMP (Annexes 1 and 15), WHO GMP, and US FDA cGMP (21 CFR 210/211) standards.
  • Assessing process safety, HVAC zoning, cleanroom classifications, and material/personnel flows for potential GMP compliance risks.
  • Reviewing validation master plans, commissioning protocols, and qualification documentation where applicable.
  • Participating in site inspections during construction and commissioning phases to verify that GMP requirements are incorporated into the physical facility.
  • Providing recommendations to DFC on GMP compliance readiness, risk mitigation, and certification status for disbursement milestones.
  • Contributing to the development of risk assessments and QA plans for GMP-critical systems.
  • Coordinating with the Field QA Engineer and MEP Engineer to ensure integrated reviews of mechanical, electrical, and HVAC systems supporting GMP compliance.
Qualifications:
  • Bachelor’s degree in Engineering (Chemical, Mechanical, or Industrial), Pharmaceutical Sciences, or a related field.
  • Minimum of 10 years of experience in GMP compliance, pharmaceutical manufacturing, or quality assurance roles.
  • Proven knowledge of WHO GMP, EU GMP (EMA), and/or US FDA cGMP (21 CFR 210/211) regulations.
  • Experience with GMP facility design reviews, process safety management, and cleanroom validation.
  • Familiarity with PIC/S guidance, ISPE Baseline Guides, and ISO 14644 (cleanroom classification).
  • Demonstrated ability to interface with international clients and donors on GMP compliance matters.
  • Strong communication skills with the ability to provide clear recommendations to management and clients.

Only highly qualified candidates will be contacted. Submitting your application gives your consent to be named to this proposal as part of GPTech’s team.:

Thank you for applying and for your interest in GP Tech. Only qualified candidates selected for further screening will be contacted. Candidates will be evaluated continuously. All are encouraged to apply as soon as possible, as employment may be contingent upon a successful background check, security clearance, and/or customer approval.

The physical demands and work environment that are described in this position description are representative of those an employee may encounter while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

This position description is a summary of the essential functions and requirements of this position. This document is not intended to be a comprehensive list of all duties and requirements of the position; at any time, the employee’s manager may assign other duties as related, or as otherwise deemed appropriate and necessary, within the general scope of the role, without the need for additional compensation.

GP Tech is proud to be an Affirmative Action/Equal Opportunity employer and encourages diversity and inclusion in the workplace. We are committed to providing equal employment opportunities for all persons, in all facets of the employment process. GP Tech prohibits the discrimination and harassment of any kind based on race, color, religion, age, gender, sexual orientation, gender identity or expression, national origin, citizenship status, marital status, parental status, genetic information, disability, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Save Apply
Report job
Other Job Recommendations:

Hypo South Production Associate - C Shift

BD
Columbus, Nebraska
$35,956 - $51,386 a year
  • Achieve production rate and quality goals on assigned...
  • Maintain all quality and GMP standards...
1 day ago

Warehouse Associate (1st shift for the DC) $18+/hr DOE

Eugene, Oregon
  • Follow allergen policies and procedures and execute...
  • Perform daily GMP and food safety audits of assigned work...
1 day ago

Locker Room Sanitation Tech

ABM Industries
Pearland, Texas
  • Perform daily cleaning and sanitization of GMP locker rooms,...
  • Follow aseptic and controlled-environment cleaning protocols...
2 days ago

Director, Commercial Operational GMP Quality (Hybrid)

Vertex Pharmaceuticals
Boston, Massachusetts
$176,000 - $264,000 a year
  • Act as a Commercial Biologics and Device Subject Matter...
  • Create Commercial Quality Operational Strategy for Biologics...
2 days ago

GMP Warehouse Operator 2

MilliporeSigma
St. Louis, Missouri
  • Contribute to the commitment to quality and safety through...
  • Works with team leads and supervisors to troubleshoot...
2 days ago