Job Description

About Nd

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.

What you will be doing:

• Protocol generation or review for the assigned areas (i.e. process equipment, facilities, utilities and laboratory equipment)
• Review vendor or construction turnover document
• Review construction walkdowns to assure compliance with design
• Support or direct execution of full C&Q project lifecycle, including URS, Design Verification, FAT, SAT, DQ, IQ, OQ and PQ etc.
• Trouble shooting equipment with a cross functional team.
• Support summary report writing wherever required
• Verification of Construction Contractor\'s Document deliverables (CTODs) and Vendor Document deliverables (VTODs).
• Support the review and revision of design document, wherever required.
• Liaise with identified stake holders, including suppliers/contractors.
• Support the handover of assigned system
• Support the management of project schedule.
• Compliant to quality and safety requirements.
• Complete trainings in a timely manner.
• Support company operation and business as required
• Any other project responsibilities specified in the individual OAN and organizational responsibilities assigned by management

• Minimally a Bachelor of Science/ Bachelor of Engineering or related scientific degree
• At least 3 years of experience in Pharmaceutical industry
• Technical knowledge in the assigned area and associated regulatory requirements, guidelines, and other industry best practices.
• Ability to work in a fast paced / dynamic work environment
• A fast learner with \xe2\x80\x9cCan-do\xe2\x80\x9d attitude
• Good time management skill and great attention to detail.
• Proficient presentation and facilitation skill is a plus.

No deviation