No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope and Responsibilities:
- Protocol generation or review for the assigned areas (i.e. process equipment, facilities, utilities, and laboratory equipment)
- Review vendor or construction turnover document
- Participate/lead system walkdowns to assure compliance with design.
- Support or direct execution of full Commissioning and Qualifying project lifecycle, including URS,
- Design Verification, FAT, SAT, DQ, IQ, OQ and PQ etc.
- Trouble shooting equipment with cross functional teams.
- Support or lead summary report writing
- Support the review and revision of design document.
- Support the handover of assigned system.
- Support the management of project schedule.
- Compliant to quality and safety requirements.
Qualifications:
- Bachelor of Science/ Bachelor of Engineering or related scientific degree
- At least 3 years of experience in Pharmaceutical industry
- In-depth 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 “Can-do” attitude
- Good time management skill and great attention to detail.
- Proficient presentation and facilitation skill is a plus.
EA License No : 19C9587
