Change Control Specialist (Pharma/Biotech)

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.
• Bachelors 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.

Information :

• Company : Nusantara Prime Consulting
• Position : Change Control Specialist (Pharma/Biotech)
• Location : Singapore
• Country : SG