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
- Lead the protocol generation and 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
- Lead 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.
- Manage 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.
- Provide SME input wherever required.
- Manage the assigned system handover.
- 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
Qualifications
- Bachelor of Science/ Bachelor of Engineering or related scientific degree
- At least 7 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 Reg. No : R2094147 EA License No : 19C9587
