
Quality Change Control Specialist
5 days ago
Roles and Responsibilities:
- Coordinate and manage change control processes across production lines.
- Collaborate with cross-functional teams to assess the impact of proposed changes on quality and manufacturing processes.
- Develop, review, and implement change control documentation, including risk assessments, implementation plans, and supporting evidence.
- Ensure timely execution and closure of change controls in compliance with regulatory requirements.
- Support investigation and documentation of deviations or discrepancies arising from changes.
- Maintain accurate records and metrics to track progress and compliance.
Key Skills and Qualifications:
- Strong organizational skills with attention to detail.
- Effective communication and collaboration skills across cross-functional teams.
- Proficiency in writing technical documentation and change justifications.
- Knowledge of electronic quality management systems and experience with GMP-regulated biopharmaceutical or pharmaceutical manufacturing environments.
Benefits:
- Opportunity to work in a dynamic and collaborative team environment.
- Chance to develop and improve existing processes and procedures.
- Competitive salary and benefits package.
About You:
- Proficient computer skills with knowledge of Microsoft Office applications.
- 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.
- Positive attitude towards work and ability to work effectively within a team environment.
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