Change Control Specialist (Pharma/Biotech)

NUSANTARA PRIME CONSULTING PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading consulting firm in Singapore is seeking a qualified individual to manage change control processes within a biopharmaceutical manufacturing environment. The successful candidate will coordinate with cross-functional teams to ensure compliance and timely execution of changes. This role requires a Bachelor's degree in a relevant field and at least 3 years of experience in a GMP-regulated setting.

Qualifications

• 3+ years of experience in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment.
• Demonstrated experience with change control systems and processes.
• Understanding of ICH Q10, FDA, EMA, and other regulatory expectations related to change management.

Responsibilities

• Serve as the primary manufacturing representative for initiating, assessing, and implementing change controls.
• Collaborate with cross-functional teams to assess the impact of proposed changes.
• Draft and review change control documentation.

Skills

Organizational skills

Attention to detail

Effective communication

Collaboration skills

Technical documentation writing

Education

Bachelor’s degree in Biotechnology, Chemical Engineering, Life Sciences

Tools

Electronic Quality Management Systems (TrackWise, Veeva)

Job description

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.