Change Control Specialist

5 days ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

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.
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