Change Control Specialist

1 week ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time
Roles & Responsibilities

Responsibilities:

  • Raise change control from end to end
  • Serve as the primary manufacturing representative for initiating, assessing, and implementing change controls impacting production processes, equipment, materials, and procedures.
  • Collaborate with cross-functional teams (QA, QC, Validation, Engineering, Supply Chain) to assess the impact of proposed changes.
  • Draft and review change control documentation, including impact assessments, implementation plans, risk assessments, and supporting evidence.
  • Ensure timely execution and closure of change controls in compliance with regulatory and company timelines.
  • Support investigation and documentation of deviations or discrepancies arising from changes.
  • Coordinate with QA to ensure proper documentation, approval, and traceability of changes.
  • Maintain change control metrics and dashboards to track progress and compliance.

Key Skills and Competencies:

  • Strong organizational and documentation skills.
  • Attention to detail and a methodical approach to process evaluation.
  • Ability to manage multiple change controls concurrently under strict deadlines.
  • Effective communication and collaboration skills across cross-functional teams.
  • Proficiency in writing technical documentation and change justifications.

About You:

  • Proficient computer skills.
  • Bachelor's degree in Biotechnology, Chemical Engineering, Life Sciences, or related discipline.
  • 3+ years of experience in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment.
  • Demonstrated experience with change control systems and processes.
  • Familiarity with electronic quality management systems (e.g., TrackWise, Veeva etc).
  • Understanding of ICH Q10, FDA, EMA, and other regulatory expectations related to change management.
  • Strong verbal and written communication skills.
  • Meticulous and attention to detail.
  • Positive and proactive attitude towards work.
  • Ability to work effectively within a collaborative team environment.
  • Motivated, keen to learn, hardworking and a good team player.
  • Able to drive projects and meet the required deadline.
Tell employers what skills you have
Technical Documentation
FDA
Assessing
Change Management
Quality Management Systems
Supply Chain
Investigation
Documentation Skills
Traceability
Biotechnology
Change Control
Evidence
Life Sciences
Chemical Engineering
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