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Process Engineering Specialists Hiring! Full Time Deviation Specialist - Deviation Management Specialist- Pharma- IMMEDIATE STARTERS in Johor - Ricebowl

Deviation Specialist - Deviation Management Specialist- Pharma- IMMEDIATE STARTERS

Process Engineering Specialists

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Working Location

  • Johor Bahru Johor Malaysia

Job Description

Responsibilities

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.


With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational clients.


This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.


We are currently looking for a Deviation Specialist to join us on a permanent role to help us deliver various projects in the Life Sciences Industry.


Key Attributes/Responsibilities

  • Manage and coordinate GMP deviation records from initiation to closure.
  • Perform or support deviation investigations related to manufacturing, equipment, utilities, facilities, processes, materials, laboratory, or documentation issues.
  • Conduct preliminary impact assessments to determine product quality, patient safety, compliance, and process impact.
  • Work with cross-functional teams such as Manufacturing, QA, QC, Engineering, Validation, MSAT, Supply Chain, and Regulatory Affairs to gather investigation inputs.
  • Support root cause analysis using appropriate tools such as 5-Why, Fishbone Diagram, or other structured investigation methods.
  • Define and track appropriate corrective and preventive actions to prevent recurrence.
  • Ensure deviation reports are written clearly, logically, and in compliance with GMP requirements.
  • Monitor deviation timelines and support timely closure of records.
  • Escalate critical or overdue deviations to relevant stakeholders.
  • Support deviation trend analysis and identify recurring issues or systemic gaps.
  • Participate in quality risk assessments where required.
  • Ensure all deviation activities comply with internal SOPs, site quality systems, and applicable regulatory requirements.
  • Support inspections, audits, and regulatory queries related to deviation management and investigations.
  • Contribute to continuous improvement of the deviation



We are currently looking for candidates in Singapore.


If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Nelson Anthony (*************).


If you would like to find out about the latest Jobs and Projects we are involved in then do follow us on LinkedIn: *************

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