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.
Responsibilities
- Lead a team, supporting the purchase, installation, commissioning and qualification of biopharmaceutical laboratory equipment in new and existing facilities
- Perform Laboratory equipment (HPLC/GC) qualification in compliant to EP, USP and PICS
- Establish qualification documentation such as User Requirement Specification, Risk Assessments, Qualification Plan, IQ/OQ/PQ protocols, Traceability Matrix and Qualification Report
- Generate Validation Summary Reports and Standard Operating Procedures (SOPs)
- Create Validation Risk Assessments
- Complete work assignments as specified by the Validation Project Manager
- Provide timely updates to the Validation Project Manager
Requirements:
- Degree qualification in Sciences, Engineering and relevant field
- Minimum 2 - 3 years of experience in performing analysis using techniques including but not limited to GC, HPLC, AAS, KF Titrator, UV-VIS
- Working experience in GMP environment is preferred