Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.
We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. With a sharp focus on delivering value-adding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services.
We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery, and cost.
At No deviation, we strive to deliver our best every day. We apply our core values of empathy, integrity, and transparency to every activity, including engagement with our candidates. We are an equal opportunity employer, value diversity, and promote inclusivity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
We are hiring for a QC Validation Engineer to support one of our clients who is a global leader in the design, engineering, and delivery of facilities for high-tech industries.
What you will be doing:
Delegate for QC system owners to support the following tasks:
To support in the AIQ, which encompasses review, approval of documents, support and provide guidance during execution activities, handle and resolve discrepancies and closure of qualification.
Review and approve commissioning/qualification documentation and exceptions.
Provide guidance and direction on commissioning/qualification activities.
Assist in change control assessments and reviews.
Conduct laboratory computer system data integrity assessments and reviews.
Collaborate with QC system owners to ensure regulatory compliance.
Ensure the qualification of lab instruments and computerized systems.
Prioritize safety, quality, and timelines in all activities.
What you will need:
Bachelor's degree in a relevant field (Chemistry, Biochemistry, Engineering, or similar).
4-5 years of working experience in a biotech or pharmaceutical operation environment.
Strong understanding of AIQ and USP general chapter requirement.
Working knowledge of lab instruments and computerized system validation (CSV).
Familiarity with change control methodology.
Good knowledge of data integrity, GMP, and GDP requirements.
Strong interpersonal, oral, and communication skills.
Ability to facilitate and collaborate effectively in a team-based environment.
Willingness to work independently and with minimal supervision.