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.
