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 & Responsibilities:
- 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
Qualifications:
- 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
