Sign upLog in
See more jobs

C&Q Specialist

Stark Pharma Solutions Inc

  • Indianapolis, IN
  • 9 days ago

    Highlights

    We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success. We are seeking an experienced C&Q Specialist to support commissioning and qualification activities within a GMP-regulated pharmaceutical manufacturing environment .

    Numbers & Facts

    LocationIndianapolis, IN

    Description

    About the Company

    Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

    Position: C&Q Specialist
    Location: Indiana, USA
    Duration: Long Term

    Job Overview

    We are seeking an experienced C&Q Specialist to support commissioning and qualification activities within a GMP-regulated pharmaceutical manufacturing environment.

    Key Responsibilities

    Execute Commissioning & Qualification (C&Q) activities for pharmaceutical manufacturing systems and equipment.
    Develop and execute IQ/OQ/PQ protocols and qualification documentation.
    Support qualification of equipment, utilities, facilities, and process systems.
    Review URS, FDS, risk assessments, SOPs, and validation documentation.
    Perform testing, troubleshoot deviations, and support investigations and CAPA activities.
    Ensure compliance with GMP, FDA, GAMP 5, and company validation procedures.
    Collaborate with Engineering, Quality, Manufacturing, Automation, and Validation teams.
    Support commissioning and qualification documentation throughout the validation lifecycle.

    Required Qualifications

    Bachelor's degree in Engineering, Life Sciences, or a related field.
    Experience in pharmaceutical or biotech C&Q/validation.
    Strong knowledge of IQ/OQ/PQ, GMP, GAMP 5, and validation lifecycle.
    Experience with pharmaceutical manufacturing equipment, facilities, utilities, or process systems.
    Experience with qualification documentation and protocol execution.
    Strong troubleshooting and problem-solving skills.
    Excellent documentation, communication, and teamwork skills.

    How to Apply

    Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

    Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.

    Similar Jobs