Deviation Writer

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

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https://www.linkedin.com/company/99455976/

Role: Deviation Writer

Location: Indiana (Onsite)

Duration: 6-Month Contract

Position Overview

We are seeking an experienced Deviation Writer to support Manufacturing Engineering and Quality Operations within a GMP-regulated pharmaceutical or biotechnology environment. This role will be responsible for authoring high-quality deviation investigations, performing root cause analysis, and collaborating with cross-functional teams to ensure timely and compliant resolution of quality events.

The ideal candidate will have strong technical writing skills, experience in deviation management, and the ability to translate complex manufacturing and engineering issues into clear, data-driven investigations.

Key Responsibilities

• Author, review, and manage deviation investigations within a GMP-regulated environment.
• Collaborate with Manufacturing, Production Engineering, MS&T, Supply Chain, Quality, and other stakeholders to gather facts and technical information.
• Conduct and document root cause investigations using structured problem-solving methodologies.
• Develop robust corrective and preventive action (CAPA) plans based on investigation outcomes.
• Analyze manufacturing and quality data to support investigation conclusions.
• Ensure investigations are completed accurately, thoroughly, and within required timelines.
• Support continuous improvement initiatives related to quality systems and manufacturing processes.
• Maintain compliance with GMP regulations, internal procedures, and quality standards.
• Simplify complex technical events into clear, concise, and audit-ready documentation.
  
  

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, or a related technical discipline.
• Minimum 3 years of experience in technical writing within a regulated GMP environment.
• Experience authoring deviation investigations in pharmaceutical, biopharmaceutical, or biotechnology manufacturing.
  
  

Strong Knowledge Of

• Root Cause Analysis
• CAPA Development
• Deviation Management
• GMP Regulations
• Experience using investigation tools such as:
• Fishbone Analysis
• 5 Whys
• Failure Analysis Techniques
• Familiarity with Electronic Quality Management Systems (eQMS).
• Strong Microsoft Word and Excel skills.
• Excellent communication, documentation, and cross-functional collaboration abilities.