Deskripsi Pekerjaan
Our client is seeking a highly skilled QC CQ Engineer (Laboratory Systems – Pharmaceutical) to join their dynamic team. In this pivotal role, you will be responsible for the validation and qualification of laboratory equipment and systems, ensuring full compliance with Good Manufacturing Practices (GMP) and regulatory standards. You will act as a technical subject matter expert, bridging the gap between engineering requirements and operational needs.
As a QC CQ Engineer, you will manage the lifecycle of system qualification, from initial gap analysis through to final reporting. This includes authoring and executing validation protocols, managing deviations, and maintaining robust documentation. The ideal candidate will thrive in a fast-paced environment, working closely with cross-functional teams to implement robust quality systems.
Tanggung Jawab
- Execute and manage IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for laboratory instrumentation and automated systems.
- Author, review, and maintain comprehensive validation documentation, including Master Validation Plans, Protocols, and Reports, ensuring strict adherence to GMP and SOPs.
- Conduct gap analysis to identify deviations between current system capabilities and regulatory requirements.
- Collaborate with vendors and internal stakeholders to resolve technical issues and implement system improvements.
- Participate in internal and external regulatory audits, providing technical support and evidence of compliance.
- Ensure all laboratory equipment calibration and maintenance activities are documented and up to date.
Kualifikasi
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related Life Sciences field.
- Minimum of 3-5 years of experience in Quality Control, Quality Assurance, or Validation Engineering within the Pharmaceutical or Life Sciences industry.
- Strong working knowledge of GMP, GLP, and FDA/EMA regulatory guidelines.
- Experience with validation of laboratory systems (e.g., LIMS, ELN, automated dispensing, environmental monitoring systems).
- Excellent verbal and written communication skills, with the ability to train and mentor junior staff.
- Proficiency in using Microsoft Office Suite and validation software tools.